Clinical trial NCT05443555: Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
Official title: Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HIV
Heavy Drinking
Keywords: Uganda
Alcohol Use
ART
HIV
Gabapentin
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-07-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Ending the HIV epidemic requires achieving HIV viral load (HVL) suppression (i.e., undetectable viral load) for key populations. Unhealthy alcohol use by people with HIV (PWH) is a barrier to reaching HVL suppression at multiple stages of the HIV care cascade. Alcohol use is common among PWH and results in lower antiretroviral therapy (ART) adherence and HVL suppression, mitigating the effectiveness of Treatment as Prevention (TasP), a key strategy for preventing HIV transmission. Treating alcohol use is therefore a mechanism to support PWH with unhealthy alcohol use along the HIV care cascade (e.g., ART initiation, retention in care, medication adherence, and HVL suppression).

The investigators propose the Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) trial to test the efficacy of gabapentin vs. placebo on achieving viral load suppression among PWH. The study population will be heavy drinkers with a detectable viral load at least 6 months after their HIV diagnosis. The rationale for this trial is that effective pharmacological alcohol treatment will help PWH with heavy alcohol use who have a known HIV diagnosis for at least 6 months to successfully engage in HIV care. The overarching strategy to achieve TasP is that gabapentin will reduce heavy alcohol use, thereby increasing HIV care engagement, ART use and adherence while decreasing pain, all of which ultimately promote viral load suppression.

GRAIL is a randomized, double-blinded, placebo-controlled clinical trial that will evaluate the efficacy of gabapentin in promoting HVL suppression via reducing alcohol use among PWH but not virally suppressed (i.e., The study population will be heavy drinkers with a detectable viral load for 6 months or more after their HIV diagnosis). Participants will be randomized 1:1 to receive either gabapentin (1800mg/day target dose) or placebo for 3 months; both arms will employ a brief intervention to reduce alcohol use.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with undetectable HIV viral load
timeFrame: 3 months post randomization
Secondary outcomes:
measure: Number of participants with undetectable HIV viral load
timeFrame: 6 months post randomization
measure: Number of participants with undetectable HIV viral load
timeFrame: 12 months post randomization
Other outcomes:
measure: Number of heavy drinking days in the past month
timeFrame: 3, 6, and 12 months post randomization
measure: Number of participants with heavy alcohol consumption defined as Phosphatidylethanol (PEth) ≥50 ng/mL
timeFrame: 3, 6, and 12 months post randomization
measure: Adherence to ART
timeFrame: 3, 6, and 12 months post randomization
measure: Percentage of ART pills taken
timeFrame: 3, 6, and 12 months post randomization
measure: Change in pain severity from baseline to follow-up
timeFrame: 3, 6, and 12 months post randomization
measure: Engagement in HIV care
timeFrame: 3, 6, and 12 months post randomization
Locations:
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
Study officials:
affiliation: Boston University
name: Jeffrey Samet, MD MA MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Karsten Lunze, MD MPH DrPH
role: PRINCIPAL_INVESTIGATOR
References: