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RECRUITINGPhase 2INTERVENTIONAL

Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

GRAIL is a Randomized Controlled Trial (RCT) among 300 HIV-positive persons with heavy alcohol consumption (by NIAAA definition) who have had detectable HIV viral load (HVL) at least 6 months after their HIV diagnosis. This trial aims to test the efficacy of gabapentin versus placebo to achieve undetectable HVL and assess the impact of gabapentin compared to placebo on alcohol consumption, pain severity, ART adherence, and engagement in HIV care. HIV viral load will be assessed at 3 (primary), 6 and 12 months via laboratory test. Eligible participants will be randomly assigned into one of two study arms: 1) gabapentin (1800mg/day target dose) for 3 months vs. 2) placebo for 3 months. All participants will receive evidence-based counseling for alcohol and either an active medication or placebo.

Who May Be Eligible (Plain English)

Who May Qualify: - Having an HIV diagnosis for at least 6 months - Current (within 2 months) detectable HIV viral load at least 6 months after HIV diagnosis - Positive EtG urine test - Able and willing to comply with all study protocols and procedures - Living within 2 hours travel time of the study site Who Should NOT Join This Trial: - Not fluent in English or Runyankole - Cognitive impairment resulting in inability to provide willing to sign a consent form based on research assessor (RA) assessment - Pregnancy, planning to become pregnant in next 3 months, or breast feeding - Taking gabapentin/pregabalin in past 30 days - Taking any medication for alcohol use disorder - Enrolled in another HIV research study seeking viral load suppression - Known hypersensitivity to gabapentin - Unstable psychiatric illness (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the emergency department (ED) or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Having an HIV diagnosis for at least 6 months * Current (within 2 months) detectable HIV viral load at least 6 months after HIV diagnosis * Positive EtG urine test * Able and willing to comply with all study protocols and procedures * Living within 2 hours travel time of the study site Exclusion Criteria: * Not fluent in English or Runyankole * Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment * Pregnancy, planning to become pregnant in next 3 months, or breast feeding * Taking gabapentin/pregabalin in past 30 days * Taking any medication for alcohol use disorder * Enrolled in another HIV research study seeking viral load suppression * Known hypersensitivity to gabapentin * Unstable psychiatric illness (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the emergency department (ED) or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations)

Treatments Being Tested

DRUG

Gabapentin

Dosing will be titrated up over 3 weeks, starting with a daily dose of 300mg (1 capsule/day) in week 1, followed by a daily dose of 900mg (3 capsules/day) in week 2, up to a target daily dose of 1800mg (6 capsules/day) in week 3. The target dose of 1800mg per day will be sustained from weeks 3 through day 4 of week 12. Then, dose will be tapered down to 900mg in days 5-7 of week 12, and medication will be discontinued at the end of week 12.

DRUG

Placebo

Participants randomized to this group will receive a placebo medication for 3 months and will be instructed to follow the same pill regimen as the intervention arm.

Locations (1)

Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
Mbarara, Uganda