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
Last Update Posted
: May 30, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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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
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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.
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- Recovery of CD4 T-lymphocytes in GALT [ Time Frame: 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.
- To measure the change in cardiovascular risk [ Time Frame: 12 months ]computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy
- changes in systemic immune activation [ Time Frame: 12 months ]decline in plasma cytokine levels (IL-6)

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Willing to sign consent form
- Naïve to ART (remote ART use >5 years will be considered on a case by case basis)
- No known GI or cardiovascular disease
- Between the ages of 18 and 60
- No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.
- All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures.
- Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease
- There are no CD4+ T-cell count or HIV plasma viral load restrictions.
Exclusion Criteria:
- Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN))
- Thrombocytopenia (platelet count <50.000 within 6 weeks)
- Contra-indications to upper endoscopy or conscious sedation
- Anemia (>grade 1 [appendix 1])
- Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
- Renal insufficiency (serum Creatinine >1.2 ULN)
- History of chronic proteinuria that could impact viread use.
- Allergy to contrast used for CT angiography
- Requirement to take medications that are contraindicated with study ART regimen.

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 |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT01869634 History of Changes |
Other Study ID Numbers: |
394080 IIS RFA _Asmuth:TMC114HIV2029 ( Other Identifier: Other ) |
First Posted: | June 5, 2013 Key Record Dates |
Last Update Posted: | May 30, 2017 |
Last Verified: | May 2017 |
Keywords provided by University of California, Davis:
HIV cardiovascular risk systemic immune activation |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Virus Diseases Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Ritonavir Darunavir Emtricitabine |
Tenofovir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |