A $12.3 million federal grant will fund a five-year UC San Diego program testing whether long-acting injectable medications can improve outcomes for people living with both HIV and methamphetamine addiction, a population researchers say has been largely shut out of clinical trials.
The National Institute on Drug Abuse, a division of the National Institutes of Health, awarded the grant to launch the Brain-Focused Research on Antiretrovirals and Methamphetamine program, known as Brain-FRAMe, according to UC San Diego. The university announced the award Monday, Aug. 17.
The clinical work will be based at the Owen Clinic in Hillcrest, UC San Diego Health's HIV primary care center, which has treated more than 3,000 patients annually since its founding in 1982, according to UC San Diego Health.
What the program will test
Brain-FRAMe's central question: can combining long-acting injectable antiretroviral therapy with addiction medication (specifically injectable naltrexone paired with oral bupropion) replace daily pills for patients whose methamphetamine use makes consistent oral treatment nearly impossible?
Methamphetamine use raises HIV infection risk by lowering risk aversion and altering immune function, according to the university. For those already living with HIV, continued use can disrupt the blood-brain barrier, impair cognition and make daily pill regimens hard to follow.
"There are people who are going to continue to use methamphetamine and who have HIV infection, and who typically have not been included in care, or who have been very difficult to maintain in care, and have been excluded from research," said Dr. Igor Grant, co-investigator and professor of psychiatry at UC San Diego School of Medicine. "We want them to get treatment. This study addresses a population that nobody has addressed before."
Who is leading the research
Mariana Cherner, a professor of psychiatry at UC San Diego School of Medicine, serves as contact principal investigator. Co-principal investigators include Dr. Scott Letendre and Dr. David Grelotti at UC San Diego's medical school, along with M. Cecilia Marcondes at San Diego Biomedical Research Institute. The broader team spans UC San Diego, UC Riverside and San Diego Biomedical Research Institute, covering psychiatry, neurology, pharmacology, virology, immunology and public health.
How the study works
Researchers will follow participants over 52 weeks using four specialized teams: a Clinical Implementation Team, a Neurobehavioral Phenotyping Team, a Biophenotyping and Pharmacology Team and a Basic Science Mechanisms Team. The biophenotyping team will analyze blood and cerebrospinal fluid to measure drug exposure and investigate viral reservoirs that may persist in the central nervous system despite treatment.
A dedicated Data Integration and Analysis Group will synthesize findings across all four teams.
If the approach proves effective, researchers say it could serve as a model for treating HIV and methamphetamine addiction simultaneously, potentially reducing new infections across San Diego and beyond. No enrollment start date has been announced.
