Trial Outcomes & Findings for Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis (NCT NCT05630872)
NCT ID: NCT05630872
Last Updated: 2026-07-20
Results Overview
Model-simulated 5th percentile and corresponding 95% confidence interval of dolutegravir (DTG) minimum concentrations (Cmin) at 50 mg BID (twice daily) when co-administered with daily rifapentine (RPT) 1200 mg plus HZM (isoniazid, pyrazinamide, and ethambutol). Pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling (FOCE-I). The final model was used to simulate 10000 individuals, incorporating parameter uncertainty. Covariates included fat-free mass on disposition parameters, rifapentine on clearance and bioavailability, and baseline unconjugated bilirubin on clearance. Measurements were taken at steady state, which was assumed to be achieved after at least 5 half-lives.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Measured at week 8 and week 21. Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
Results posted on
2026-07-20
Participant Flow
Participants were enrolled at four sites, three in South Africa and one in Thailand. Participants were enrolled between February and December 2024.
Participant milestones
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
Dolutegravir (DTG)-based antiretroviral therapy (ART) at 50 mg twice daily (BID) was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg once a day (QD).
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|---|---|
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Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
Dolutegravir (DTG)-based antiretroviral therapy (ART) at 50 mg twice daily (BID) was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg once a day (QD).
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|---|---|
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Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Participants with data available
Baseline characteristics by cohort
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=30 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Age, Continuous
|
35 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
South Africa
|
27 Participants
n=30 Participants
|
|
Region of Enrollment
Thailand
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3 Participants
n=30 Participants
|
|
BMI
Underweight: <18.5 kg/m2
|
9 Participants
n=30 Participants
|
|
BMI
Healthy Weight: 18.5 to <25 kg/m2
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19 Participants
n=30 Participants
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|
BMI
Overweight: 25 to <30 kg/m2
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1 Participants
n=30 Participants
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|
BMI
Obese: 30+ kg/m2
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1 Participants
n=30 Participants
|
|
HIV-1 RNA
|
4.99 log10 copies/mL
n=30 Participants
|
|
CD4
|
185 10^6 CD4 cells/L
n=28 Participants • Participants with data available
|
|
Tuberculosis (TB) regimen prior to study entry
HRZE
|
18 Participants
n=30 Participants
|
|
Tuberculosis (TB) regimen prior to study entry
None
|
12 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Measured at week 8 and week 21. Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.Population: Participants with pharmacokinetic data available.
Model-simulated 5th percentile and corresponding 95% confidence interval of dolutegravir (DTG) minimum concentrations (Cmin) at 50 mg BID (twice daily) when co-administered with daily rifapentine (RPT) 1200 mg plus HZM (isoniazid, pyrazinamide, and ethambutol). Pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling (FOCE-I). The final model was used to simulate 10000 individuals, incorporating parameter uncertainty. Covariates included fat-free mass on disposition parameters, rifapentine on clearance and bioavailability, and baseline unconjugated bilirubin on clearance. Measurements were taken at steady state, which was assumed to be achieved after at least 5 half-lives.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=28 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Model-simulated 5th Percentile and Corresponding 95% Confidence Interval of DTG Cmin at 50 mg BID When Co-administered With Daily RPT 1200 mg Plus HZM
|
0.30 ug/mL
Interval 0.2 to 0.41
|
SECONDARY outcome
Timeframe: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.Population: Participants with confirmed evaluable PK profiles available. This includes participants who adhered to the protocol-defined dosing schedule and had no issues affecting data integrity.
Primary pharmacokinetic (PK) parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=28 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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DTG Minimum Concentration (Cmin)
Week 8
|
0.70 ug/mL
Interval 0.53 to 0.91
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|
DTG Minimum Concentration (Cmin)
Week 21
|
0.82 ug/mL
Interval 0.6 to 1.12
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SECONDARY outcome
Timeframe: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.Population: Participants with confirmed evaluable PK profiles available. This includes participants who adhered to the protocol-defined dosing schedule and had no issues affecting data integrity.
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=28 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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DTG Maximum Concentration (Cmax)
Week 8
|
2.72 ug/mL
Interval 2.35 to 3.14
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|
DTG Maximum Concentration (Cmax)
Week 21
|
3.60 ug/mL
Interval 3.16 to 4.1
|
SECONDARY outcome
Timeframe: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.Population: Participants with confirmed evaluable PK profiles available. This includes participants who adhered to the protocol-defined dosing schedule and had no issues affecting data integrity.
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=28 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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DTG Area Under the Concentration-time Curve (AUC0-24)
Week 8
|
37.0 ug*h/mL
Interval 30.8 to 44.6
|
|
DTG Area Under the Concentration-time Curve (AUC0-24)
Week 21
|
47.3 ug*h/mL
Interval 39.3 to 57.0
|
SECONDARY outcome
Timeframe: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.Population: Participants with confirmed evaluable PK profiles available. This includes participants who adhered to the protocol-defined dosing schedule and had no issues affecting data integrity.
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=28 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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DTG Clearance
Week 8
|
2.70 L/h
Interval 2.24 to 3.25
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|
DTG Clearance
Week 21
|
1.06 L/h
Interval 0.88 to 1.27
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SECONDARY outcome
Timeframe: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.Population: Participants with confirmed evaluable PK profiles available. This includes participants who adhered to the protocol-defined dosing schedule and had no issues affecting data integrity.
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=28 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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DTG Terminal Half Life
Week 8
|
4.51 hours
Interval 4.08 to 4.99
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|
DTG Terminal Half Life
Week 21
|
10.10 hours
Interval 8.76 to 11.64
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SECONDARY outcome
Timeframe: Week 6 through week 17Population: All participants who started dolutegravir
The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=29 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Percent of Participants Who Experienced Grade 3 or Higher Adverse Events (AE)
|
20.7 percent of participants
Interval 8.0 to 39.7
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SECONDARY outcome
Timeframe: Week 6 through week 17Population: All participants who started dolutegravir.
The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=29 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Percent of Participants Who Experienced Rifamycin Hypersensitivity
|
0.0 percent of participants
Interval 0.0 to 11.6
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SECONDARY outcome
Timeframe: Week 6 through week 17Population: All participants who started dolutegravir.
Drug-induced liver injury was defined as alanine animotransferase (ALT) ≥3xULN (upper limit of normal) with symptoms/jaundice or ALT ≥5xULN. The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=29 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Percent of Participants Who Experienced Drug-induced Liver Injury
|
0.0 percent of participants
Interval 0.0 to 11.6
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SECONDARY outcome
Timeframe: Week 6 through week 17Population: All participants who started dolutegravir.
The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17. Study treatment discontinuation included discontinuing either ART, TB treatment, or both.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=29 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Percent of Participants Who Prematurely Discontinued Study Treatment
|
3.4 percent of participants
Interval 0.1 to 17.8
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SECONDARY outcome
Timeframe: Weeks 10, 14, 21, and 30Population: Participants who started dolutegravir and were on study provided ART at the time of the assessment
Viral suppression is defined as HIV-1 RNA below 50 copies/mL.
Outcome measures
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=28 Participants
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Percent of Participants With Viral Suppression
Week 10
|
60.7 percent of participants
Interval 40.6 to 78.5
|
|
Percent of Participants With Viral Suppression
Week 14
|
89.3 percent of participants
Interval 71.8 to 97.7
|
|
Percent of Participants With Viral Suppression
Week 21
|
100 percent of participants
Interval 87.2 to 100.0
|
|
Percent of Participants With Viral Suppression
Week 30
|
81.8 percent of participants
Interval 59.7 to 94.8
|
Adverse Events
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=30 participants at risk
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
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|---|---|
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Infections and infestations
Clostridium difficile colitis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Meningitis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
Arthropod bite
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
Other adverse events
| Measure |
Adults With HIV and Newly Diagnosed DS-TB Not Currently on ART
n=30 participants at risk
Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD.
|
|---|---|
|
Renal and urinary disorders
Renal impairment
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
Productive cough
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
6.7%
2/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Eye disorders
Eye pain
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Eye disorders
Visual impairment
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Immune system disorders
Drug hypersensitivity
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Anal abscess
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Body tinea
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Oral candidiasis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Subcutaneous abscess
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
|
6.7%
2/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
Face injury
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood glucose increased
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood pressure increased
|
10.0%
3/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood sodium decreased
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Haemoglobin decreased
|
6.7%
2/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Hepatic enzyme increased
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Weight decreased
|
6.7%
2/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
|
10.0%
3/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
2/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
Arthralgia
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
Musculoskeletal stiffness
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Facial paresis
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
|
6.7%
2/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
Angioedema
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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
Pruritus
|
6.7%
2/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria were collected. The DAIDS AE Grading Table (V2.1) was used. All eligible participants who initiated study treatment are included.
|
|
Vascular disorders
Vascular pain
|
3.3%
1/30 • From study entry to study completion at Week 48 or premature study discontinuation
All Grade ≥2 adverse events (AEs), all AEs that led to a change in treatment regardless of grade, and all AEs meeting serious adverse event definition or expedited adverse event reporting criteria 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