Faculty Collaboration Database

The setpoint study (ACTG A5217): effect of immediate versus deferred antiretroviral therapy on virologic set point in recently HIV-1-infected individuals. J Infect Dis 2012 Jan 01;205(1):87-96

Date

12/20/2011

Pubmed ID

22180621

Pubmed Central ID

PMC3242744

DOI

10.1093/infdis/jir699

Scopus ID

2-s2.0-84555189233 (requires institutional sign-in at Scopus site)   94 Citations

Abstract

BACKGROUND: The benefits of antiretroviral therapy during early human immunodeficiency virus type 1 (HIV-1) infection remain unproved.

METHODS: A5217 study team randomized patients within 6 months of HIV-1 seroconversion to receive either 36 weeks of antiretrovirals (immediate treatment [IT]) or no treatment (deferred treatment [DT]). Patients were to start or restart antiretroviral therapy if they met predefined criteria. The primary end point was a composite of requiring treatment or retreatment and the log(10) HIV-1 RNA level at week 72 (both groups) and 36 (DT group).

RESULTS: At the June 2009 Data Safety Monitoring Board (DSMB) review, 130 of 150 targeted participants had enrolled. Efficacy analysis included 79 individuals randomized ≥72 weeks previously. For the primary end point, the IT group at week 72 had a better outcome than the DT group at week 72 (P = .005) and the DT group at week 36 (P = .002). The differences were primarily due to the higher rate of progression to needing treatment in the DT group (50%) versus the IT (10%) group. The DSMB recommended stopping the study because further follow-up was unlikely to change these findings.

CONCLUSIONS: Progression to meeting criteria for antiretroviral initiation in the DT group occurred more frequently than anticipated, limiting the ability to evaluate virologic set point. Antiretrovirals during early HIV-1 infection modestly delayed the need for subsequent treatment.

CLINICAL TRIALS REGISTRATION: NCT00090779.

Author List

Hogan CM, Degruttola V, Sun X, Fiscus SA, Del Rio C, Hare CB, Markowitz M, Connick E, Macatangay B, Tashima KT, Kallungal B, Camp R, Morton T, Daar ES, Little S, A5217 Study Team

Author

Christine Hogan MD Assistant Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adenine
Adult
Anti-HIV Agents
Deoxycytidine
Disease Progression
Drug Administration Schedule
Drug Combinations
Drug Therapy, Combination
Emtricitabine
Female
HIV Infections
HIV-1
Humans
Lopinavir
Male
Organophosphonates
RNA, Viral
Ritonavir
Tenofovir
Treatment Outcome
Viral Load