The HIV Prevention Trials Network (HPTN), which includes McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), has launched a study to evaluate whether a new injectable medication can work as well as an existing oral pill to safely protect against HIV among men who have sex with men (MSM) and transgender women (TGW) who have sex with men.
The trial will help determine whether a new HIV prevention drug called cabotegravir, which can be injected into the body every two months, is as safe and effective as Truvada®, a daily oral pill that contains tenofovir disoproxil fumarate and emtricitabine. Cabotegravir is an integrase inhibitor, which blocks an HIV enzyme and prevents the virus from multiplying. Researchers believe that the long-lasting nature of the injectable drug may make it easier to adhere to than a daily oral medication.
"We are very excited to bring access to a prevention trial with a promising long-acting drug for Houstonians at risk for HIV infection. This novel prevention strategy aims to improve adherence, which is directly linked to efficacy," said Roberto C. Arduino, M.D., professor of medicine in the Division of Infectious Diseases at McGovern Medical School at UTHealth and principal investigator of the Houston site, which will enroll 100 participants in the trial.
Trial participants will be enrolled through Harris Health System's Thomas Street Health Center, an outpatient clinic in Houston where UTHealth physicians see patients. Arduino will collaborate with Baylor College of Medicine researchers in the enrollment and follow-up of participants for the study.
People who are at risk of becoming infected with HIV will be assigned randomly to either the injectable drug or the oral drug group. Study participants will be transitioned to local HIV prevention services when their participation in the study ends. Participation in the trial could range from 1.5 to 4.5 years, depending on when a person enrolls in the trial.
The United States, Argentina, Brazil, Peru, Thailand, Vietnam and South Africa are among the countries participating in the clinical trial, which will enroll 4,500 participants and last up to four and a half years.