Trial Outcomes & Findings for A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV (NCT NCT05630885)
NCT ID: NCT05630885
Last Updated: 2025-07-16
Results Overview
Target-to-Background Ratio (TBR) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid), relative to its respective blood background. Specifically, it is the ratio of the Standardized Uptake Value (SUV) of 18-FDG-PET in the target vessel to SUV in the blood background. A negative number for the change in TBR means a reduction in the target arterial wall inflammation over time. Index vessel is the vessel with the highest vessel TBR at baseline. The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the ratio of TBR at week 24 to baseline. For the statistical analyses, results for the 6 and 9 missing values in Arm A and Arm B, respectively, were imputed using multiple imputation by regression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Measured at baseline and week 24
Results posted on
2025-07-16
Participant Flow
110 participants were enrolled from 19 US clinical research sites between May 30, 2023 and January 5, 2024.
Participants were randomized 2:1 to CVC arm (Arm A) or placebo for CVC arm (Arm B) and stratified by statin use status (current statin use or no current statin use) at study entry (enrollment).
Participant milestones
| Measure |
CVC Arm (Arm A)
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Study Completion
STARTED
|
74
|
36
|
|
Study Completion
COMPLETED
|
70
|
36
|
|
Study Completion
NOT COMPLETED
|
4
|
0
|
|
Efficacy Analysis Population Set
STARTED
|
70
|
36
|
|
Efficacy Analysis Population Set
COMPLETED
|
59
|
34
|
|
Efficacy Analysis Population Set
NOT COMPLETED
|
11
|
2
|
Reasons for withdrawal
| Measure |
CVC Arm (Arm A)
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Study Completion
Took prohibited medications
|
2
|
0
|
|
Study Completion
Non-compliance with study drug
|
1
|
0
|
|
Study Completion
Adverse Event
|
1
|
0
|
|
Efficacy Analysis Population Set
Took prohibited medications
|
3
|
1
|
|
Efficacy Analysis Population Set
Prematurely discontinued study treatment before week 22
|
8
|
1
|
Baseline Characteristics
Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
Baseline characteristics by cohort
| Measure |
CVC Arm (Arm A)
n=74 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=36 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
eGFR Groups
90+
|
32 Participants
n=74 Participants
|
8 Participants
n=36 Participants
|
40 Participants
n=110 Participants
|
|
CD4 Count
|
656 cells/mm^3
n=74 Participants
|
681 cells/mm^3
n=36 Participants
|
666 cells/mm^3
n=110 Participants
|
|
CD4 Percent
|
35.3 %
n=74 Participants
|
34.0 %
n=36 Participants
|
34.8 %
n=110 Participants
|
|
HIV-1 RNA
< Lower Limit of Quantification (LLQ)
|
70 Participants
n=74 Participants
|
31 Participants
n=36 Participants
|
101 Participants
n=110 Participants
|
|
HIV-1 RNA
≥ Lower Limit of Quantification (LLQ)
|
4 Participants
n=74 Participants
|
5 Participants
n=36 Participants
|
9 Participants
n=110 Participants
|
|
Age, Continuous
|
58 years
n=74 Participants
|
58 years
n=36 Participants
|
58 years
n=110 Participants
|
|
Age, Customized
Age Groups · 45-54
|
25 Participants
n=74 Participants
|
11 Participants
n=36 Participants
|
36 Participants
n=110 Participants
|
|
Age, Customized
Age Groups · 55-64
|
37 Participants
n=74 Participants
|
16 Participants
n=36 Participants
|
53 Participants
n=110 Participants
|
|
Age, Customized
Age Groups · 65-74
|
12 Participants
n=74 Participants
|
8 Participants
n=36 Participants
|
20 Participants
n=110 Participants
|
|
Age, Customized
Age Groups · 75+
|
0 Participants
n=74 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=110 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=74 Participants
|
7 Participants
n=36 Participants
|
30 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=74 Participants
|
29 Participants
n=36 Participants
|
80 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=74 Participants
|
8 Participants
n=36 Participants
|
21 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=74 Participants
|
28 Participants
n=36 Participants
|
89 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=74 Participants
|
12 Participants
n=36 Participants
|
38 Participants
n=110 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=74 Participants
|
24 Participants
n=36 Participants
|
70 Participants
n=110 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=110 Participants
|
|
Gender Identity
Cisgender
|
72 Participants
n=74 Participants
|
36 Participants
n=36 Participants
|
108 Participants
n=110 Participants
|
|
Gender Identity
Transgender Spectrum
|
2 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=110 Participants
|
|
Body Mass Index (BMI)
|
28.5 kg/m^2
n=74 Participants
|
28.7 kg/m^2
n=36 Participants
|
28.5 kg/m^2
n=110 Participants
|
|
BMI Groups
Underweight (< 18.5)
|
0 Participants
n=74 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=110 Participants
|
|
BMI Groups
Normal (18.5 - 24.9)
|
16 Participants
n=74 Participants
|
11 Participants
n=36 Participants
|
27 Participants
n=110 Participants
|
|
BMI Groups
Overweight (25 - 29.9)
|
31 Participants
n=74 Participants
|
8 Participants
n=36 Participants
|
39 Participants
n=110 Participants
|
|
BMI Groups
Obese (30+)
|
27 Participants
n=74 Participants
|
17 Participants
n=36 Participants
|
44 Participants
n=110 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
86 mL/min/1.73m^2
n=74 Participants
|
77 mL/min/1.73m^2
n=36 Participants
|
82 mL/min/1.73m^2
n=110 Participants
|
|
eGFR Groups
< 60
|
3 Participants
n=74 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=110 Participants
|
|
eGFR Groups
60 - < 90
|
39 Participants
n=74 Participants
|
25 Participants
n=36 Participants
|
64 Participants
n=110 Participants
|
|
Antiretroviral Therapy (ART) Class
INSTI-based
|
53 Participants
n=74 Participants
|
27 Participants
n=36 Participants
|
80 Participants
n=110 Participants
|
|
Antiretroviral Therapy (ART) Class
NNRTI-based
|
12 Participants
n=74 Participants
|
7 Participants
n=36 Participants
|
19 Participants
n=110 Participants
|
|
Antiretroviral Therapy (ART) Class
INSTI and NNRTI-based
|
9 Participants
n=74 Participants
|
2 Participants
n=36 Participants
|
11 Participants
n=110 Participants
|
|
Count of High-Risk Cardiovascular Risk Factors
One
|
12 Participants
n=74 Participants
|
4 Participants
n=36 Participants
|
16 Participants
n=110 Participants
|
|
Count of High-Risk Cardiovascular Risk Factors
Two
|
21 Participants
n=74 Participants
|
7 Participants
n=36 Participants
|
28 Participants
n=110 Participants
|
|
Count of High-Risk Cardiovascular Risk Factors
Three
|
18 Participants
n=74 Participants
|
10 Participants
n=36 Participants
|
28 Participants
n=110 Participants
|
|
Count of High-Risk Cardiovascular Risk Factors
Four or more
|
23 Participants
n=74 Participants
|
15 Participants
n=36 Participants
|
38 Participants
n=110 Participants
|
|
Statin-use at Entry
Current-use of Statins
|
42 Participants
n=74 Participants
|
19 Participants
n=36 Participants
|
61 Participants
n=110 Participants
|
|
Statin-use at Entry
No Current-use of Statins
|
32 Participants
n=74 Participants
|
17 Participants
n=36 Participants
|
49 Participants
n=110 Participants
|
|
Index Vessel
Aorta
|
45 Participants
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
23 Participants
n=32 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
68 Participants
n=90 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Index Vessel
Left Carotid Artery
|
6 Participants
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
3 Participants
n=32 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
9 Participants
n=90 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Index Vessel
Right Carotid Artery
|
7 Participants
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
6 Participants
n=32 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
13 Participants
n=90 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Index Vessel Most-Diseased Segment (MDS) Target-to-Background Ratio (TBR)
|
2.26 Ratio
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.22 Ratio
n=32 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.23 Ratio
n=90 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Aorta Vessel TBR
|
2.12 Ratio
n=57 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.02 Ratio
n=31 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.10 Ratio
n=88 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Left Carotid Artery Vessel TBR
|
1.75 Ratio
n=46 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.80 Ratio
n=21 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.76 Ratio
n=67 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Right Carotid Artery Vessel TBR
|
1.81 Ratio
n=47 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.82 Ratio
n=22 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.81 Ratio
n=69 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Bilateral Carotid Arteries Vessel TBR
|
1.78 Ratio
n=46 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.78 Ratio
n=21 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.78 Ratio
n=67 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Aorta Vessel Standard Uptake Value (SUV)
|
1.85 SUV
n=57 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.94 SUV
n=33 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.92 SUV
n=90 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Bilateral Carotid Arteries Vessel SUV
|
1.58 SUV
n=51 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.79 SUV
n=21 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.65 SUV
n=72 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
C-Reactive Protein (hsCRP)
|
1.44 mg/L
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.69 mg/L
n=33 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.71 mg/L
n=91 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Interleukin-6
|
1.57 pg/mL
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.02 pg/mL
n=33 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1.79 pg/mL
n=91 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Soluble CD14
|
1403 ng/mL
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1435 ng/mL
n=33 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1415 ng/mL
n=91 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Soluble CD163
|
729 ng/mL
n=57 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
720 ng/mL
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
729 ng/mL
n=91 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
MCP-1
|
171 pg/mL
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
184 pg/mL
n=33 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
175 pg/mL
n=91 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
MIP-1 alpha
< Lower Limit of Quantification (LLQ)
|
58 Participants
n=59 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
33 Participants
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
91 Participants
n=93 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
MIP-1 alpha
Missing
|
1 Participants
n=59 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1 Participants
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2 Participants
n=93 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
MIP-1 beta
< Lower Limit of Quantification (LLQ)
|
10 Participants
n=59 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
4 Participants
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
14 Participants
n=93 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
MIP-1 beta
≥ Lower Limit of Quantification (LLQ)
|
48 Participants
n=59 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
29 Participants
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
77 Participants
n=93 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
MIP-1 beta
Missing
|
1 Participants
n=59 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
1 Participants
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2 Participants
n=93 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
MIP-1 beta
|
52.1 pg/mL
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
55.3 pg/mL
n=33 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
52.4 pg/mL
n=91 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
RANTES
|
69.7 ng/mL
n=57 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
70.2 ng/mL
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
69.7 ng/mL
n=91 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Fasting Glucose
|
95 mg/dL
n=59 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
95 mg/dL
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
95 mg/dL
n=93 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Fasting Insulin
|
9.02 uIU/mL
n=58 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
10.4 uIU/mL
n=34 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
9.90 uIU/mL
n=92 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
|
Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
|
2.01 HOMA-IR Index
n=53 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.50 HOMA-IR Index
n=32 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
2.35 HOMA-IR Index
n=85 Participants • Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
|
PRIMARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population: all enrolled participants who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
Target-to-Background Ratio (TBR) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid), relative to its respective blood background. Specifically, it is the ratio of the Standardized Uptake Value (SUV) of 18-FDG-PET in the target vessel to SUV in the blood background. A negative number for the change in TBR means a reduction in the target arterial wall inflammation over time. Index vessel is the vessel with the highest vessel TBR at baseline. The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the ratio of TBR at week 24 to baseline. For the statistical analyses, results for the 6 and 9 missing values in Arm A and Arm B, respectively, were imputed using multiple imputation by regression.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=53 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=25 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel.
|
0.95 Fold-change
Interval 0.85 to 1.01
|
0.93 Fold-change
Interval 0.87 to 1.02
|
SECONDARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
Target-to-Background Ratio (TBR) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid), relative to its respective blood background. Specifically, it is the ratio of the Standard Uptake Value (SUV) of 18-FDG-PET in the target vessel to SUV in the blood background. A negative number for the change in TBR implies a reduction in the target arterial wall inflammation over time. The results are expressed as the ratio of TBR at week 24 to baseline.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=55 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=27 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs)
Aorta TBR
|
1.00 Fold-change
Interval 0.93 to 1.09
|
0.99 Fold-change
Interval 0.91 to 1.11
|
|
Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs)
Bilateral Carotid TBR
|
0.99 Fold-change
Interval 0.89 to 1.09
|
1.02 Fold-change
Interval 0.89 to 1.11
|
SECONDARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
Standard Uptake Value (SUV) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid). Specifically, it is the average of all evaluable SUV for a given arterial vessel. A negative number for the change in SUV implies a reduction in the target arterial wall inflammation over time. The results are expressed as the ratio of SUV at week 24 to baseline.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=56 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=28 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta
Aorta SUV
|
1.00 Fold-change
Interval 0.93 to 1.11
|
1.00 Fold-change
Interval 0.88 to 1.1
|
|
Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta
Bilateral Carotid SUV
|
1.02 Fold-change
Interval 0.94 to 1.11
|
1.00 Fold-change
Interval 0.89 to 1.06
|
SECONDARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
Fasting glucose (mg/dL) measures the level of sugar (glucose) in the blood after fasting (no eating or drinking except water) for at least 8 hours. Higher value of change means an increase in glucose levels over time. The results are expressed as the change in fasting glucose from baseline to week 24.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=58 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=34 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change in Fasting Glucose
|
1.00 mg/dL
Interval -9.0 to 8.0
|
-0.50 mg/dL
Interval -13.0 to 8.0
|
SECONDARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
Insulin is a hormone crucial in regulating blood sugar levels. HOMA-IR is a calculation used to assess insulin resistance and is calculated with the formula: insulin (uIU/mL) \* glucose (mg/dL) / 405. Higher value of change in insulin and HOMA-IR means an increase in insulin resistance over time. The results are expressed as the ratio of fasting insulin or HOMA-IR at week 24 to baseline.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=58 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=33 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Fasting insulin
|
0.91 Fold-change
Interval 0.67 to 1.28
|
0.89 Fold-change
Interval 0.57 to 1.31
|
|
Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
HOMA-IR
|
0.85 Fold-change
Interval 0.63 to 1.37
|
0.90 Fold-change
Interval 0.46 to 1.48
|
SECONDARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
The cytokine, Interleukin-6 (IL-6, pg/mL); protein, high-sensitivity C Reactive Protein (hsCRP, mg/L); and chemokine, monocyte chemoattractant protein-1 (MCP-1, pg/mL) are all markers of inflammation. Higher value of change means an increase in the biomarker levels over time. Higher levels of these biomarkers indicates inflammation. MCP-1 is a ligand of CCR2 that was expected to increase with CVC. The results are expressed as the ratio of hsCRP, IL-6, or MCP-1 at week 24 to baseline.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=58 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=33 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)
hsCRP
|
0.85 Fold-change
Interval 0.51 to 1.3
|
0.84 Fold-change
Interval 0.61 to 1.48
|
|
Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)
Interleukin-6
|
0.99 Fold-change
Interval 0.78 to 1.64
|
1.10 Fold-change
Interval 0.71 to 1.56
|
|
Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)
MCP-1
|
5.00 Fold-change
Interval 3.96 to 6.04
|
0.99 Fold-change
Interval 0.86 to 1.36
|
SECONDARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
The soluble proteins soluble-CD14 (sCD14, ng/mL) and soluble-CD163 (sCD163, ng/mL) are all markers of monocyte/macrophage activation. Higher value of change means an increase in the biomarker levels over time. Higher levels of sCD14 and sCD163 occur in response to inflammation and infection. The results are expressed as the difference between sCD14 or sCD163 from baseline to week 24.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=58 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=33 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change in Biomarkers of Immune Activation (sCD14 and sCD163)
Soluble CD14
|
-16.2 ng/mL
Interval -147.0 to 112.0
|
6.66 ng/mL
Interval -115.0 to 155.0
|
|
Change in Biomarkers of Immune Activation (sCD14 and sCD163)
Soluble CD163
|
-21.8 ng/mL
Interval -93.9 to 50.5
|
17.4 ng/mL
Interval -67.3 to 68.8
|
SECONDARY outcome
Timeframe: Measured at baseline and week 24Population: Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications.
The chemokines macrophage inflammatory protein-1 alpha and beta (MIP-1 alpha and beta, pg/mL) as well as the chemokine, RANTES (ng/mL), are markers of inflammation. Higher value of change means an increase in the biomarker levels over time. Higher levels of these biomarkers indicates inflammation. RANTES and MIP-1 beta are ligands of CCR5 that were expected to increase with CVC. The results are expressed as the ratio of RANTES or MIP-1 beta at week 24 to baseline.
Outcome measures
| Measure |
CVC Arm (Arm A)
n=58 Participants
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=33 Participants
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta)
MIP-1 beta
|
2.44 Fold-change
Interval 1.82 to 3.54
|
1.07 Fold-change
Interval 0.92 to 2.07
|
|
Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta)
RANTES
|
0.98 Fold-change
Interval 0.8 to 1.22
|
1.06 Fold-change
Interval 0.92 to 1.29
|
Adverse Events
CVC Arm (Arm A)
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo for CVC Arm (Arm B)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CVC Arm (Arm A)
n=74 participants at risk
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=36 participants at risk
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection viral
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood triglycerides increased
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Myelopathy
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Psychiatric disorders
Intentional self-injury
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Reproductive system and breast disorders
Priapism
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
Other adverse events
| Measure |
CVC Arm (Arm A)
n=74 participants at risk
Participants with pre-existing ART regimen of EFV took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg.
CVC 150 mg: Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mg: Administered as two 150-mg tablets by mouth once a day with food.
|
Placebo for CVC Arm (Arm B)
n=36 participants at risk
Participants with pre-existing ART regimen of EFV took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg.
Placebo for CVC 150 mg: Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mg: Administered as two 150-mg matching placebo tablets by mouth once a day with food.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Anal fissure
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Pyrexia
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
COVID-19
|
8.1%
6/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
5.6%
2/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Influenza
|
2.7%
2/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Onychomycosis
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Paronychia
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Sinusitis
|
2.7%
2/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Viral infection
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.7%
2/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Amylase increased
|
5.4%
4/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood cholesterol increased
|
2.7%
2/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood creatinine decreased
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood creatinine increased
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood glucose increased
|
5.4%
4/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
8.3%
3/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood sodium increased
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood triglycerides increased
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
5.6%
2/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Creatinine renal clearance decreased
|
6.8%
5/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
11.1%
4/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Glomerular filtration rate decreased
|
28.4%
21/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
13.9%
5/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Haemoglobin decreased
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Low density lipoprotein increased
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Cervical radiculopathy
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Migraine
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Psychiatric disorders
Drug abuse
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Reproductive system and breast disorders
Uterine polyp
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
2.8%
1/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Vascular disorders
Hypertension
|
1.4%
1/74 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
0.00%
0/36 • From study entry to completion at Week 24 or premature study discontinuation.
All adverse events (AE) that met reporting criteria as defined in Protocol v2.0 Section 7.2 were collected. The DAIDS AE Grading Table (v2.1) was used. All eligible participants who initiated study treatment are included.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER