Injectable Cabotegravir for HIV Prevention

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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).

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

My recent lab tests show I am in good health.

I am a man who has sex with men or a transgender woman, 18 or older, and was male at birth.

Willing to provide informed consent for the study

+2 more

Exclusion Criteria

I have a history of liver disease or liver abnormalities.

Active or recent use of any illicit intravenous drugs (defined as in the 90 days prior to enrollment)

QTc interval greater than 500 msec

+11 more

Participant Groups

The trial is testing cabotegravir (CAB LA), an injectable drug for pre-exposure prophylaxis (PrEP) against HIV. It compares CAB LA's safety and effectiveness to TDF/FTC tablets (current PrEP standard). Some participants will receive placebos instead of active drugs as part of the study design.

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment3 Interventions

In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.

Group II: Arm AExperimental Treatment4 Interventions

In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.

Cabotegravir is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Vocabria for: