Actively Recruiting
Led by Boston Medical Center · Updated on 2025-11-06
220
Participants Needed
1
Research Sites
39 weeks
Total Duration
B
Boston Medical Center
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
Researchers are evaluating the use of gabapentin to reduce alcohol consumption and improve HIV viral load suppression in people living with HIV who have heavy alcohol use and a detectable HIV viral load at least 6 months after diagnosis. This Phase 2 randomized controlled trial aims to test gabapentin's effect compared to placebo on achieving an undetectable viral load, as well as its impact on alcohol use, pain severity, adherence to antiretroviral therapy (ART), and engagement in HIV care. Participants will be randomly assigned to receive either gabapentin or placebo for 3 months, both combined with brief evidence-based counseling for alcohol use. Gabapentin dosing will start at 300mg daily in week 1, increase to 900mg daily in week 2, and reach a target dose of 1800mg daily from week 3 through most of week 12, followed by tapering and discontinuation by the end of week 12. The placebo group will follow an identical pill regimen without active medication. During the study, HIV viral load will be measured at 3, 6, and 12 months after randomization to assess viral suppression. Participants will be monitored for alcohol use, ART adherence, pain severity, and engagement in HIV care. The trial includes regular laboratory tests and counseling sessions, with participant involvement lasting at least 12 months to track these outcomes and safety.
CONDITIONS
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either gabapentin or placebo for 3 months along with brief counseling to reduce alcohol use.
Weekly visits for up to 12 weeks
Duration - Up to 9 months after treatment
Participants are monitored for viral load suppression and other outcomes after the treatment period ends.
Visits at 3, 6, and 12 months post randomization
Total: 1 location
1
Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
Mbarara, Uganda
Actively Recruiting
J
Jeffrey Samet, MD MA MPH
K
Karsten Lunze, MD MPH DrPH
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Ve Truong, Allen Kekibiina, Winnie Muyindike...
https://pubmed.ncbi.nlm.nih.gov/41282191