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Gabapentin for å redusere alkohol og forbedre undertrykkelse av viral belastning (GRAIL)

4. november 2026 oppdatert av: Boston Medical Center

Gabapentin for å redusere alkohol og forbedre undertrykkelse av viral belastning - fremmer "behandling som forebygging"

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

220

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Legemiddel: 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.
Placebo komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with undetectable HIV viral load
Tidsramme: 3 months post randomization

Assessed by study test
3 months post randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with undetectable HIV viral load
Tidsramme: 6 months post randomization

Assessed by study test
6 months post randomization
Number of participants with undetectable HIV viral load
Tidsramme: 12 months post randomization

Assessed by study test
12 months post randomization

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of heavy drinking days in the past month
Tidsramme: 3, 6, and 12 months post randomization

Assessed by self-report using the Timeline Followback method
3, 6, and 12 months post randomization
Number of participants with heavy alcohol consumption defined as Phosphatidylethanol (PEth) ≥50 ng/mL
Tidsramme: 3, 6, and 12 months post randomization

Assessed by study test
3, 6, and 12 months post randomization
Adherence to ART
Tidsramme: 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
Percentage of ART pills taken
Tidsramme: 3, 6, and 12 months post randomization

Assessed by self-report
3, 6, and 12 months post randomization
Change in pain severity from baseline to follow-up
Tidsramme: 3, 6, and 12 months post randomization

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
Engagement in HIV care
Tidsramme: 3, 6, and 12 months post randomization

Defined as ≥ 1 HIV visit in the past 3 months assessed by medical record review
3, 6, and 12 months post randomization

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boston Medical Center

Samarbeidspartnere

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Etterforskere

  • Hovedetterforsker: Jeffrey Samet, MD MA MPH, Boston University
  • Hovedetterforsker: Karsten Lunze, MD MPH DrPH, Boston University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. november 2023

Primær fullføring (Faktiske)

24. september 2026

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

29. juni 2022

Først innsendt som oppfylte QC-kriteriene

29. juni 2022

Først lagt ut (Faktiske)

5. juli 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H-42904
  • R01AA030460 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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