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)

Must not be taking: TDF/FTC

Disqualifiers: HIV, Cardiovascular disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 11

4570 Participants Needed

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

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

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

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

Group I: Arm B Experimental Treatment 3 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 A Experimental Treatment 4 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

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

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

Trials

1,150

Recruited

878,000+

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