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N/A N=151 Randomized Treatment

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

HIV Infection

Enrolled (actual)
151
Serious AEs
0.7%
Results posted
Mar 2022
Primary outcome: Primary: Baseline HIV DNA Reservoir: Total HIV DNA — 3.83; 3.67; 3.40 Log10 HIV DNA copies/10^6 CD4 T cells — p=0.048

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ART initiation at time of HIV diagnosis (Drug); ART at 24 weeks (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Fred Hutchinson Cancer Center
Primary completion
Nov 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Baseline HIV DNA Reservoir: Total HIV DNA
3.83; 3.67; 3.40 0.048 sig
PRIMARY
Two Phase Decay of HIV DNA Reservoir: Total HIV DNA
-0.145; -0.058; -0.018; -0.006; -0.004; -0.001 <0.0001 sig
PRIMARY
Baseline HIV DNA Reservoir: Integrated HIV DNA
2.87; 2.76; 2.55 >0.05
PRIMARY
Two Phase Decay of HIV DNA Reservoir: Integrated HIV DNA
-0.149; -0.049; -0.014; -0.002; -0.001; -0.001 <0.0001 sig
PRIMARY
Baseline HIV DNA Reservoir: TILDA Stimulation
2.94; 2.02; 1.66 0.057
PRIMARY
Two Phase Decay of HIV DNA Reservoir: TILDA Stimulation
-0.266; -0.170; -0.143; -0.002; -0.001; 0.001 0.010 sig
PRIMARY
HIV DNA Integration Sites
PRIMARY
GI Microbiome
PRIMARY
Levels of Inflammatory Markers
PRIMARY
Impact of Alcohol Use
PRIMARY
HIV RNA Viral Load
6.63; 5.42; 4.96; 1.6; 1.6; 1.6
PRIMARY
CD4 Count
656; 609; 552; 622; 584; 635
PRIMARY
Time to Undetectable HIV Viral Load
163.5; 110; 154

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • counter-indication for use of study antiretroviral drugs
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02744040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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