Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet
Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
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.