Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
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|ClinicalTrials.gov Identifier: NCT01869634|
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : March 4, 2020
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Infection||Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: 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.
Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily
Other Name: darunavir (Prezista®) 800 mg with ritonavir 100 mg and Truvada® to be taken once daily
No Intervention: 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.
- 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 [ Time Frame: Baseline, 12 months ]CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.
- Change in Percentage of Total Artery Diameter [ Time Frame: Baseline, 12 months ]computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy
- Change in Systemic Immune Activation [ Time Frame: Baseline, 12 months ]Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869634
|United States, California|
|University of California Davis|
|Sacramento, California, United States, 95617|