Viewing Study NCT01694420



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Last Modification Date: 2024-10-26 @ 10:57 AM
Study NCT ID: NCT01694420
Status: COMPLETED
Last Update Posted: 2017-04-12
First Post: 2012-09-21

Brief Title: Treatment of Acute HIV Infection With Quad Fixed-dose Combination FDC Tablet
Sponsor: Duke University
Organization: Duke University

Study Overview

Official Title: Treatment of Acute HIV Infection With the Elvitegravir Cobicistat Emtricitabine and Tenofovir Disoproxil Fumarate A Pilot Study of Response to Therapy and HIV Pathogenesis
Status: COMPLETED
Status Verified Date: 2017-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PHI04
Brief Summary: This is a multicenter single arm 48-week open-label study of FDC ELVCOBIFTCTDF 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 ELVCOBIFTCTDF 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 ELVCOBIFTCTDF

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 RNAml 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 EFVFTCTDF 2 compared to historical controls treated with EFVFTCTDF plasma HIV RNA will decrease more rapidly in PHI participants treated with ELVCOBIFTCTDF 3 compared to historical controls treated with EFVFTCTDF 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 ELVCOBIFTCTDF 4in 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 ELVCOBIFTCTDF will demonstrate improved viral clearance in these compartments as compared to historical controls treated with EFVFTCTDF 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 EFVFTCTDF In addition we will compare these results to those measured in HIV-1 infected participants treated and 6 ELVCOBIFTCTDF will be well tolerated and the proportion of participants who require treatment modification will be less than that observed in participants treated with EFVFTCTDF
Detailed Description: None desired

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
IN-US-236-0124 OTHER_GRANT Funder None