DURHAM, N.C. – The HIV Prevention Trials Network (HPTN) has launched a new study, HPTN 083, to evaluate whether injectable cabotegravir (CAB) can safely protect men who have sex with men (MSM) and transgender women (TGW) who have sex with men from acquiring HIV as well as daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). If found to be safe and effective for HIV pre-exposure prophylaxis, also known as PrEP, injectable CAB may be easier for some people to adhere to than daily oral TDF/FTC. The U.S., Canada, South Africa, Kenya, Peru, France and Australia are among countries where TDF/FTC is approved for use as PrEP.
“The annual number of new HIV infections among young people, especially MSM and TGW who have sex with men, has been on the rise despite nearly flat HIV incidence worldwide,” said HPTN 083 protocol chair Raphael J. Landovitz, M.D., M.Sc. “It is essential to develop multiple effective HIV prevention modalities so the most vulnerable populations have a choice of preventive options. We hope injectable cabotegravir will become one such modality.” Dr. Landovitz is an associate professor of medicine in the Division of Infectious Diseases at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and associate director of the UCLA Center for Clinical AIDS Research & Education (CARE).
HPTN 083 will enroll approximately 4,500 HIV-uninfected cisgender MSM and TGW who have sex with men in the U.S., Argentina, Brazil, Peru, India, Thailand, Vietnam, and South Africa. The study will last up to 4.5 years. HIV uninfected persons who are at increased risk of HIV acquisition will be assigned by chance to either CAB or TDF/FTC in a double-blind manner. This means that neither the participant nor the staff will know what the person is receiving. Study participants will be transitioned to locally available HIV prevention services when their participation in the study ends.
“The HPTN 083 study has the potential to be a game changer as the first large-scale test of a long-acting injectable drug for HIV prevention,” said HPTN 083 protocol co-chair Beatriz Grinsztejn, M.D., Ph.D. Dr. Grinsztejn directs the Instituto de Pesquisa Clinica Evandro Chagas HIV/AIDS Clinical Research Centre of the Oswaldo Cruz Foundation-Fiocruz in Rio de Janeiro, Brazil. The HPTN 083 study is jointly funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and ViiV Healthcare. Study drugs are provided by ViiV Healthcare and Gilead Sciences, Inc.
"There is a sense of urgency to develop more tools for HIV prevention. If demonstrated to be effective, long acting injectable cabotegravir will provide an important option independent of adherence to a daily regimen,” said Myron Cohen, M.D., co-principal investigator for the HPTN and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill.
For more information about HPTN 083, visit hptn.org, or ClinicalTrials.gov using study identifier NCT02720094.
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN research agenda is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions. NIH funds HPTN. For more information, visit hptn.org.
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**India is no longer an HPTN 083 site as of 2017