Cook County Health & Hospitals System's ( CCHHS ) Ruth M. Rothstein CORE Center is taking part in the first large-scale clinical trial of a long-acting injectable drug for HIV prevention.
The HPTN 083 study will evaluate whether an investigational anti-HIV drug called cabotegravir, which can be taken once every 8 weeks, can safely protect men and transgender women from HIV infection as well as the anti-HIV medication Truvada. Truvadaconsisting of two anti-HIV drugs emtricitabine and tenofovir disoproxil fumaratemust be taken once a day to be effective, and it has been shown to reduce the risk of HIV infection in people who are at high risk by up to 92 percent.
Dr. Temitope Oyedele, who is the lead investigator for the study at the CORE Center, said Truvada "has been shown to be effective as pre-exposure prophylaxis against HIV, but the biggest problem is that a lot of people don't remember to take it every day."
"What makes this study so important is it could provide a viable alternative where patients won't have to take a pill every day, but could instead get an injection once every two months and be protected," said Dr. Oyedele, an Attending Physician in the Division of Infectious Diseases at CCHHS' John H. Stroger Jr., Hospital.
HPTN 083 will enroll approximately 4,500 HIV-uninfected men or transgender women who have sex with men at 45 sites in eight countries, including the U.S. and countries in Africa, Asia and South America. Participants must be 18 years or older to participate in the study and be at high risk of getting HIV.
The study will last up to 4.5 years, and participants will be transitioned to locally available HIV prevention services when their participation in the study ends.
The study is sponsored by the National Institutes of Health. ViiV Healthcare and Gilead Sciences ( the manufacturers of cabotegravir and Truvada respectively ) are providing the study medications.
For more information about HPTN 083, visit ClinicalTrials.gov using study identifier NCT02720094.
Contact the CORE Center to learn more about taking part in the trial by calling ( 312 ) 869-4289.