CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
ART initiation at time of HIV diagnosis +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • Men who have sex with men or transgender women
  • HIV-infected with prior participation in SABES study in Lima Peru OR Established HIV infection OR HIV uninfected
Key exclusion· 1
  • Contraindication for use of study antiretroviral drugs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02744040
NCT02744040N/ACompleted

Modulating the Impact of Critical Events in Early HIV Infection: Effect of ART Initiation and Alcohol Use

Fred Hutchinson Cancer Center·interventional·Posted Apr 20, 2016·Updated Mar 29, 2022

In Brief

A clinical study evaluating ART initiation at time of HIV diagnosis and ART at 24 weeks for HIV Infection. Completed, enrolled 151 participants across 1 site.

Detailed Summary

The overall objective is to determine the influence of timing of ART initiation and alcohol consumption on HIV disease course. ART initiation immediately after HIV infection largely results in smaller HIV reservoir and lower HIV-associated systemic inflammation, which has been linked to non-AIDS morbidity and mortality. Immediate ART also reduces HIV-associated bacterial translocation and may prevent intestinal microbiome dysbiosis, that has been linked to increased systemic inflammation. Immediate intervention is not, however, generally feasible and more information is required about the consequences of starting ART at later time-points, but still early after acquisition. The study will be conducted in Lima, Peru, in a cohort of 180 MSM and transgender women (TW) with acute (Ab-, HIV RNA+) or recent (≤ 3 months) HIV infection. Alcohol use disorder (AUDIT score ≥8) is present in \~50% of HIV + participants in our cohort, four times higher than that seen among males in the general Peruvian population. Although the role of alcohol use in HIV pathogenesis and disease course remains unclear, some studies show a correlation with accelerated disease progression. The effects of alcohol resemble early post-infection changes in bacterial translocation and pro-inflammatory cytokines induced by HIV and their impact on HIV disease course before and after ART initiation remain unexplored. Specific Aim 1: To determine the relative long-term benefits of immediate vs. early vs. delayed ART initiation at 24 weeks after diagnosis. The investigators will study outcomes after 2 and 4 years in MSM and TW diagnosed with acute or recent HIV infection. Specific Aim 2: To determine the impact of alcohol use on the relative long-term benefits of immediate vs. early vs. delayed initiation of ART.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 20, 2016
Enrollment StartAug 28, 2017
Primary CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.2 years ago

Interventions

ART initiation at time of HIV diagnosisdrug

Immediate ART initiation

ART at 24 weeksdrug

ART initiation 24 weeks after enrollment