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

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.

Conditions

• HIV Infection

Interventions

DRUG

ART initiation at time of HIV diagnosis

Immediate ART initiation

DRUG

ART at 24 weeks

ART initiation 24 weeks after enrollment

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Asociación Civil Impacta Salud y Educación, Peru

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Ann Duerr · Fred Hutchinson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-28

Primary Completion

2020-11-30

Completion

2020-11-30

Countries

• Peru

Study Locations