HIV Clinical Trial - Treatment of Acute HIV Infection With Quad Fixed-dose

Status Active, not recruiting

Clinical Trial Summary

This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF [Stribild] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and study drug (ELV/COBI/FTC/TDF) will be provided for the first 48 weeks. After week 48, clinical care but not study drug will be provided through week 96. A study participant suppressed at week 48 can continue on FDC ELV/COBI/FTC/TDF.

The primary hypothesis is that once daily fixed-dose combination elvitegravir (ELV), cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) will rapidly reduce viral replication to <50 copies RNA/ml in participants with acute HIV infection. The secondary hypotheses to be considered are 1) virologic response rates as measured by plasma HIV RNA levels will be non-inferior or superior to a historical group of participants from the PHI cohort treated with EFV/FTC/TDF, 2) compared to historical controls treated with EFV/FTC/TDF, plasma HIV RNA will decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 3) compared to historical controls treated with EFV/FTC/TDF, immune activation as measured by the proportion CD4+ and CD8+ cells expressing HLA-DR and CD38+ will decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 4)in a subset of participants samples will be obtained from compartments such as the gastrointestinal tract, and lymphoid tissues to assess changes over time in parameters such as HIV-1 RNA, immunologic responses to HIV, and tissue and anatomic reservoirs. We hypothesize that treatment with the ELV/COBI/FTC/TDF will demonstrate improved viral clearance in these compartments as compared to historical controls treated with EFV/FTC/TDF. 5) in a subset of participants who remain suppressed on therapy, resting CD4 cells with replication-competent HIV-1 (latent reservoir) will be quantitated and compared to similar measurements in PHI participants treated with EFV/FTC/TDF. In addition, we will compare these results to those measured in HIV-1 infected participants treated and 6) ELV/COBI/FTC/TDF will be well tolerated, and the proportion of participants who require treatment modification will be less than that observed in participants treated with EFV/FTC/TDF.

Clinical Trial Description

None desired ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01694420
Study type	Interventional
Source	Duke University
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	September 2012
Completion date	February 2017

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet — PHI04

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms