Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Gabapentin til at reducere alkohol og forbedre viral belastningsundertrykkelse (GRAIL)

4. november 2026 opdateret af: Boston Medical Center

Gabapentin for at reducere alkohol og forbedre viral belastningsundertrykkelse - Fremme "behandling som forebyggelse"

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

220

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston Medical Center

Samarbejdspartnere

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. november 2023

Primær færdiggørelse (Faktiske)

24. september 2026

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

29. juni 2022

Først indsendt, der opfyldte QC-kriterier

29. juni 2022

Først opslået (Faktiske)

5. juli 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner