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HIVPhase 2GRAILNCT05443555

Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

A Phase 2 study testing Gabapentin in people with HIV and Heavy Drinking, run by Boston Medical Center at 1 site in Uganda.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Heavy Drinking
What is being tested?
Gabapentin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteUganda
Study dates
20 Nov 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Uganda1 site

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

    Mbarara

Other trials in Uganda

About this study

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

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.

Read the 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.

Conditions
HIV, Heavy Drinking
Being tested
Gabapentin, Placebo
Keywords
Uganda, Alcohol Use, ART, HIV, Gabapentin
Medical subject headings
Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GabapentinDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT05443555
Study groupRoleWhat they receive
Intervention: GabapentinActive comparatorParticipants randomized to the intervention group will receive active gabapentin for 3 months and brief (5-minute) evidence-based counseling for alcohol use.
Receives: Drug: Gabapentin
Control: PlaceboPlacebo comparatorParticipants randomized to the control group will receive placebo capsules, identical in appearance to gabapentin, and the same brief (5-minute) one-time evidence-based counseling for alcohol use as the intervention group.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with undetectable HIV viral load

    Assessed by study test

    Measured: 3 months post randomization

Secondary outcomes (2)

  1. Number of participants with undetectable HIV viral load

    Assessed by study test

    Measured: 6 months post randomization

  2. Number of participants with undetectable HIV viral load

    Assessed by study test

    Measured: 12 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start20 Nov 2023
  3. Primary completion24 Sep 2026
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443555
Sponsor's protocol ID
H-42904
Other IDs
R01AA030460
Acronym
GRAIL
Status last verified
Nov 2026
First submitted
29 Jun 2022
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Truong V, Kekibiina A, Muyindike WR, Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn JA, Allison O, Bullard MJ, Lunze K, Samet JH. Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL). Trials. 2026 Jun 3;27(1):452. doi: 10.1186/s13063-026-09813-1.

    PubMed 42237416

  • Truong V, Kekibiina A, Muyindike W, Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn J, Allison O, Bullard MJ, Lunze K, Samet JH. Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL). Res Sq [Preprint]. 2025 Oct 15:rs.3.rs-6856284. doi: 10.21203/rs.3.rs-6856284/v1.

    PubMed 41282191

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gabapentin in people with HIV and Heavy Drinking, run by Boston Medical Center at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with undetectable HIV viral load (time frame: 3 months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443555, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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