Long-acting Cabotegravir Formulations in Healthy Adults

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: ViiV Healthcare

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants. The study will initially start with the assessment of Cabotegravir Formulation F. Once the clinical batch of Cabotegravir Formulation G is available, this formulation will be assessed.

Eligibility Criteria

Healthy adults over 40 kg and BMI of 18-32, not pregnant or breastfeeding, with no major health issues. Must test negative for COVID-19 on admission day, agree to use effective contraception, and have no history of drug abuse or high-risk behaviors for HIV infection.

Inclusion Criteria

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

I was assigned female at birth, am not pregnant or breastfeeding, and meet one of the required conditions.

I tested negative for COVID-19 on the day I was admitted.

+6 more

Exclusion Criteria

My blood pressure is not normal.

I have a genetic blood clotting disorder like haemophilia or VWD.

History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.

+26 more

Participant Groups

The trial is testing two different long-acting formulations of Cabotegravir (Formulation F followed by G) in healthy participants to assess their safety, tolerability, and how the body processes them.

2Treatment groups

Experimental Treatment

Group I: Part B: Participants receiving Cabotegravir Formulation GExperimental Treatment1 Intervention

Group II: Part A: Participants receiving Cabotegravir Formulation FExperimental Treatment1 Intervention