Injectable Cabotegravir for HIV Prevention
Trial Summary
What is the purpose of this trial?
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Research Team
Raphael J. Landovitz, MD, MSc
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
This trial is for HIV-uninfected cisgender men and transgender women who have sex with men, are at high risk of acquiring HIV, and in general good health. Participants must be willing to consent, have a negative HIV test, no significant liver disease or cardiovascular issues, not use illicit intravenous drugs recently or be on certain medications that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Step 1
Participants receive daily oral CAB or TDF/FTC and corresponding placebo for 5 weeks
Step 2
Participants receive CAB LA injections every 8 weeks or TDF/FTC with placebo injections to Week 153
Step 3
All participants receive daily oral TDF/FTC for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cabotegravir
- TDF/FTC
Cabotegravir is already approved in European Union, United States, Canada, Japan for the following indications:
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
ViiV Healthcare
Industry Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine