Pharmacokinetic and Pharmacodynamic Evaluation of Etonogestrel Dose Escalation With Efavirenz-based Antiretroviral Therapy in HIV-infected Ugandan

PRO17080453

This study will evaluate the frequency of ovulation and cervical mucus quality of HIV-infected women on efavirenz (EFV)-based antiretroviral therapy (ART) using either a single etonogestrel (ENG) implant or two ENG implants for at least one year.

2019-02-19

2020-12-22

2022-10-25

Completed

Early phase I

72

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study. 2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Women age 18 years to 40 years 4. Diagnosed with HIV infection 5. Medically eligible for the ENG subdermal implant as a contraceptive method based on the WHO Medical Eligibility Criteria for Contraceptive Use20 6. Receiving EFV-based ART for a minimum of 3 months prior to screening 7. Must agree to have concurrent highly effective non-hormonal contraception with a copper IUD, if not previously medically sterilized. 8. Participants must report regular menses (bleeding for 4-8 days at 21 to 35 day intervals) for the preceding 2 month 9. Participants must have a negative urine pregnancy test at entry and report no unprotected sex since the last menstrual period or in the last two weeks. Exclusion Criteria: 1. HIV RNA \> 50 copies/mL at screening visit 2. Serum hemoglobin \< 10.0 g/dl 3. Elevations in serum levels of alanine transaminase (ALT) above 5 times the upper limit of normal 4. Elevations in serum creatinine above 2.5 times the upper limit of normal 5. Use of drugs known to be contraindicated with ENG or EFV within 30 days of study entry. Due to the dynamic nature of drug interactions related to ART, the study team will review all concomitant medications at screening based on the US Department of Health and Human Services drug interaction table45 and the ENG implant product labeling15. 6. Currently pregnant or postpartum \<30 days at study entry. 7. Breastfeeding women within 6 months of delivery. 8. Use of hormonal contraception in the preceding 3 months prior to entry 9. Participants determined to be ineligible for IUD placement by the WHO Medical Eligibility Criteria for Contraceptive Use46 10. Patients with a history of hypersensitivity to ENG implant, undiagnosed vaginal bleeding, diagnosed or suspected sex hormone dependent neoplasia, benign or malignant liver tumor, or thromboembolic disease. 11. Presence of any active clinically significant disease or life-threatening disease that, in the investigator's opinion, would compromise the subject's safety or outcome of the study.

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2023-03-13