4570 Participants Needed

Injectable Cabotegravir for HIV Prevention

Recruiting at 43 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

RJ

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

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
See 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
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Step 1

Participants receive daily oral CAB or TDF/FTC and corresponding placebo for 5 weeks

5 weeks
2 visits (in-person)

Step 2

Participants receive CAB LA injections every 8 weeks or TDF/FTC with placebo injections to Week 153

148 weeks
Every 8 weeks (in-person)

Step 3

All participants receive daily oral TDF/FTC for 48 weeks

48 weeks
Quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks
Quarterly visits (in-person)

Treatment Details

Interventions

  • Cabotegravir
  • TDF/FTC
Trial Overview 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.
Participant Groups
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 for the following indications:

🇪🇺
Approved in European Union as Vocabria for:
  • HIV-1 infection
🇺🇸
Approved in United States as Vocabria for:
  • HIV-1 infection
🇨🇦
Approved in Canada as Vocabria for:
  • HIV-1 infection
🇯🇵
Approved in Japan as Vocabria for:
  • HIV-1 infection

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

ViiV Healthcare

Industry Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

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