Trial Outcomes & Findings for Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART (NCT NCT01869634)
NCT ID: NCT01869634
Last Updated: 2020-03-04
Results Overview
CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Baseline, 12 months
Results posted on
2020-03-04
Participant Flow
Participant milestones
| Measure |
HIV Positive Naive to ART
HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.
darunavir with ritonavir and fixed-dose viread+emtricitabine daily
|
Normal Control Volunteers
HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Baseline characteristics by cohort
| Measure |
HIV Positive Naive to ART
n=18 Participants
HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.
darunavir with ritonavir and fixed-dose viread+emtricitabine daily
|
Normal Control Volunteers
n=17 Participants
HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40 years
n=99 Participants
|
37 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
17 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
CD4+ T-cells
|
215 cells/mm^3
n=99 Participants
|
460 cells/mm^3
n=107 Participants
|
310 cells/mm^3
n=206 Participants
|
|
HIV viral load
|
41032 copies/ml
n=99 Participants
|
0 copies/ml
n=107 Participants
|
41032 copies/ml
n=206 Participants
|
|
weight
|
187 lbs
n=99 Participants
|
194 lbs
n=107 Participants
|
191 lbs
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: HIV negative participants underwent the procedures only once at Screening (entry). In the HIV group the comparison between before and after ART was done using a Wilcoxon signed-rank test.
CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.
Outcome measures
| Measure |
HIV Positive Naive to ART
n=18 Participants
HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.
darunavir with ritonavir and fixed-dose viread+emtricitabine daily
|
Normal Control Volunteers
n=17 Participants
HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
|
|---|---|---|
|
Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
Entry
|
80 cells / mm^2
Interval 34.0 to 190.0
|
478 cells / mm^2
Interval 389.0 to 627.0
|
|
Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
12-months after ART
|
213 cells / mm^2
Interval 120.0 to 292.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: We compare wall thickness between HIV+ infected individuals and in the HIV group before and after 12-months of ART.
computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy
Outcome measures
| Measure |
HIV Positive Naive to ART
n=15 Participants
HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.
darunavir with ritonavir and fixed-dose viread+emtricitabine daily
|
Normal Control Volunteers
n=14 Participants
HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
|
|---|---|---|
|
Change in Percentage of Total Artery Diameter
|
57 % of total artery diameter
Interval 54.0 to 61.0
|
53 % of total artery diameter
Interval 50.0 to 56.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 monthsChange in systemic immune activation, as measured by change in plasma cytokine levels (IL-6).
Outcome measures
| Measure |
HIV Positive Naive to ART
n=18 Participants
HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.
darunavir with ritonavir and fixed-dose viread+emtricitabine daily
|
Normal Control Volunteers
n=17 Participants
HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
|
|---|---|---|
|
Change in Systemic Immune Activation
|
1.74 pg/ml
Interval 1.42 to 2.15
|
0.66 pg/ml
Interval 0.5 to 0.81
|
Adverse Events
HIV Positive Naive to ART
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Control Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Asmuth, Professor of Medicine
University of California, Davis Health, Department of Internal Medicine
Phone: 916-734-8695
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place