NCT05156658

Pharmacokinetic Interactions of ENG Subdermal Implants with Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA)

Pharmacokinetic Interactions of Etonogestrel (ENG) Subdermal Implants with Long-Acting (LA) Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA) in Participants of Reproductive Potential

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this pharmacokinetic (PK) trial is to evaluate whether the ENG implant, a long-acting birth control method, is tolerable and effective for adults with HIV who are taking long-acting cabotegravir (CAB-LA) and long-acting rilpivirine (RPV-LA). Access to safe and effective birth control for adults with HIV is important because it may result in fewer infants exposed to HIV in the womb or born with HIV. Researchers believe that people of childbearing potential need access to birth control options that do not need to be negotiated with a partner.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Etonogestrel (ENG) Subdermal Implants	Etonogestrel is available as a single, white/off-white, soft, radiopaque, flexible, ethylene vinyl acetate copolymer implant, 4 cm in length and 2 mm in diameter containing 68 mg of etonogestrel. Store at 25°C (77°F); excursions permitted between 15 and 30°C (59-86°F) \[see USP Controlled Room Temperature\]. Avoid storing ENG at temperatures above 30°C (86°F).

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2021-12-14
• Last updated: 2024-12-13

Regulatory

• FDA-regulated drug study