ACTG A5392: 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
Treatment Category: Treatment Experienced
The Etonogestrel (ENG) subdermal implant is used for birth control. In women without HIV, the ENG implant can prevent pregnancy for up to 3 years. Cabotegravir (CAB) and Rilpivirine (RPV) are anti-HIV drugs. The combination of CAB Long Acting and RP Long Acting (CARLA) can be administered by injection every 4 weeks to control the HIV infection. It is possible that using ENG and RPV together could decrease how long ENG will prevent pregnancy, or could impact how well RPV or CAB work to maintain viral suppression. In this study participants living with HIV who are already receiving CARLA will be given the ENG implant. Participants without HIV will be given an ENG implant.
Study Status: Open
Why is this study being done?
- To see if ENG implants can be used together with CARLA without increasing the risk of pregnancy or the risk of losing control of HIV viral
- The levels of ENG in blood will be compared between the two The levels of CAB and RPV will also be compared before and after starting the implant.
Who can join?
- Are female at birth, and 18 years of age or older
- Are living with HIV-1 who have good control of HIV infection, are already receiving CARLA, and who agree to use another non-hormonal form of birth control
- OR are without HIV
- Had their last menstrual period ≤35 days prior to study entry
- Are willing to have the ENG implant inserted
- Are not currently pregnant or breastfeeding, and have not participated in sexual activity in the last 14 days without
What do I need to do in the study?
Participants living with HIV receiving monthly CARLA (not provided by study) will receive: ENG subdermal implant.
Participants living without HIV will receive: ENG subdermal implant.
All participants will be on study treatment for 48 weeks. At the end of the study, participants may choose to keep the ENG implant or have it removed.
What treatments or drugs are involved with this study?
Etonogestrel (ENG) subdermal implant is a thin rod about the size of a matchstick that is inserted under the skin on the inner side of the upper arm. It contains a drug (ENG) that is used for birth control. The implant can be removed at any time if a woman wants to become pregnant. The anti-HIV medications, a combination of CAB Long Acting and RPV Long Acting (CARLA), are injected every 4 weeks, and will not be provided by the study.