Gabapentina para reduzir o álcool e melhorar a supressão da carga viral (GRAIL)
Gabapentina para Reduzir o Álcool e Melhorar a Supressão da Carga Viral - Promovendo o "Tratamento como Prevenção"
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Mbarara, Uganda
- Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Intervention: Gabapentin
Participants randomized to the intervention group will receive active gabapentin for 3 months and brief (5-minute) evidence-based counseling for alcohol use. |
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. |
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Comparador de Placebo: Control: Placebo
Participants 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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with undetectable HIV viral load
Prazo: 3 months post randomization
|
Assessed by study test |
3 months post randomization
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with undetectable HIV viral load
Prazo: 6 months post randomization
|
Assessed by study test |
6 months post randomization
|
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Number of participants with undetectable HIV viral load
Prazo: 12 months post randomization
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Assessed by study test |
12 months post randomization
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of heavy drinking days in the past month
Prazo: 3, 6, and 12 months post randomization
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Assessed by self-report using the Timeline Followback method |
3, 6, and 12 months post randomization
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Number of participants with heavy alcohol consumption defined as Phosphatidylethanol (PEth) ≥50 ng/mL
Prazo: 3, 6, and 12 months post randomization
|
Assessed by study test |
3, 6, and 12 months post randomization
|
|
Adherence to ART
Prazo: 3, 6, and 12 months post randomization
|
Measured by participants' drawing a line on a Visual Analog Scale, which ranges from 0 to 100. ≥80% indicates adherence to ART. |
3, 6, and 12 months post randomization
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Percentage of ART pills taken
Prazo: 3, 6, and 12 months post randomization
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Assessed by self-report |
3, 6, and 12 months post randomization
|
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Change in pain severity from baseline to follow-up
Prazo: 3, 6, and 12 months post randomization
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Assessed by Brief Pain Inventory with a range of scores from 0 (none) to 10 (high) where lower scores are favorable. |
3, 6, and 12 months post randomization
|
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Engagement in HIV care
Prazo: 3, 6, and 12 months post randomization
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Defined as ≥ 1 HIV visit in the past 3 months assessed by medical record review |
3, 6, and 12 months post randomization
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeffrey Samet, MD MA MPH, Boston University
- Investigador principal: Karsten Lunze, MD MPH DrPH, Boston University
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Comportamento de beber
- Comportamento
- Beber álcool
- Aminoácidos, peptídeos e proteínas
- Produtos químicos orgânicos
- Hidrocarbonetos
- Ciclohexanos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Ácidos, acíclico
- Ácidos carboxílicos
- Aminas
- Aminoácidos
- Ácido gama-aminobutírico
- Aminobutiratos
- Butyrates
- Ácidos, carbocíclicos
- Ácidos ciclohexanecarboxílicos
- Gabapentina
Outros números de identificação do estudo
- H-42904
- R01AA030460 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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