The GRAIL Study (R01AA030460): Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
In this issue of URBAN ARCH News, we highlight the affiliated NIAAA-funded Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) study. The GRAIL study was funded in September 2022 to examine the efficacy of gabapentin vs placebo in achieving undetectable HIV viral load, and will take place in Mbarara, Uganda.
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 GRAIL study chose to investigate gabapentin, as it has demonstrated efficacy for decreasing alcohol consumption and preventing relapse of use.
The specific aims of GRAIL are:
- To test the efficacy of gabapentin vs placebo in attaining undetectable HVL (Primary Outcome at 3 months; Secondary Outcome at 6 & 12 months).
- To evaluate the impact of gabapentin vs placebo on: a) alcohol consumption; b) pain severity; c) ART adherence; and d) engagement in HIV care, in order to investigate possible mechanisms by which gabapentin may result in HVL suppression.
GRAIL is a 2-arm, randomized, double-blinded, placebo-controlled clinical trial. The study aims to enroll 300 participants (150 per arm with arm 1 taking a 1800mg/day target dose of gabapentin for 3 months, and arm 2 taking a placebo for 3 months) from a population of PWH with a detectable viral load for 6 months or more after their HIV diagnosis who are also heavy drinkers. The study will take place at Mbarara University of Science and Technology (MUST) and will be executed by an impressive team of researchers led by Dr. Jeffrey Samet and Dr. Karsten Lunze (MPIs), Dr. Winnie Muyindike (site PI), Dr. Judith Hahn, and Dr. Judith Tsui (co-investigators).
In March 2023, study staff and investigators came together in Mbarara to meet in-person and to conduct study training. The team was also able to gather with the TALC study team for a combined study launch party. Overall, this time together was valuable for the team and allowed for in-depth training on study procedures as well as team bonding.
Allen Kekibiina, GRAIL field coordinator, shared that she is “excited to learn the mechanisms of how gabapentin works on viral load suppression, reduction of alcohol consumption, ART adherence and pain severity. I’m optimistic about the potential of the study and I’m excited to see how it unfolds.” You can read more about Allen and her work background in HIV/alcohol research in this issue’s spotlight interview.
Dr. Jeffrey Samet’s take on this treatment as prevention (TasP) strategy is that “it’s a very pragmatic, somewhat longshot, approach to intervening with those patients with HIV who have been unable achieve HIV viral load suppression. Uganda, with its strong research team and high prevalence of HIV and alcohol use disorder, is an excellent site to examine this alcohol/HIV clinical challenge.”
Currently, the GRAIL team is working on finalizing study documents and data collection systems. They hope to begin enrolling participants this fall, and they are excited to see where the results of this innovative study will lead in the long term!
