Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women

Inclusion Criteria

• Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
• Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Women aged 18 years to 40 years.
• Diagnosed with HIV infection.
• Medically eligible for the etonogestrel subdermal implant as a contraceptive method.
• Receiving efavirenz-based anti-retroviral therapy for a minimum of 3 months prior to screening.
• Must agree to have concurrent highly effective non-hormonal contraception with a copper intrauterine device, if not previously medically sterilized.
• Participants must report regular menses (bleeding for 4-8 days at 21- to 35-day intervals) for the preceding 2 months.
• 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

• HIV RNA > 50 copies/mL at screening visit.
• Serum hemoglobin < 10.0 g/dL.
• Elevations in serum levels of alanine transaminase above 5 times the upper limit of normal.
• Elevations in serum creatinine above 2.5 times the upper limit of normal.
• Use of drugs known to be contraindicated with etonogestrel or efavirenz within 30 days of study entry. Due to the dynamic nature of drug interactions related to antiretroviral therapy, the study team will review all concomitant medications at screening for drug interactions with efavirenz and the etonogestrel implant.
• Currently pregnant or postpartum less than 30 days at study entry.
• Breastfeeding women within 6 months of delivery.
• Use of hormonal contraception in the preceding 3 months prior to entry
• Participants determined to be ineligible for intrauterine device placement.
• Patients with a history of hypersensitivity to etonogestrel implant, undiagnosed vaginal bleeding, diagnosed or suspected sex hormone dependent neoplasia, benign or malignant liver tumor, or thromboembolic disease.
• 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.