A Pharmacokinetic Evaluation of Etonogestrel (ENG) Implant and Antiretroviral Therapy

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Antiretroviral therapy (medicines used to treat HIV) can interact with hormonal contraceptives which might decrease their effectiveness. The single-rod etonogestrel contraceptive implant is being more commonly used in low- and middle-income countries because if the ease of insertion and removal. Efavirenz and nevirapine are first-line HIV medicines in Sub-Saharan Africa and this study will help determine an effective way to use these medicines with the etonogestrel implant. The investigators hypothesize that women receiving nevirapine- or efavirenz-based antiretroviral therapy will have lower etonogestrel levels in their blood after six months of insertion as compared to women not taking antiretroviral therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Makerere University
• Treatments: Desogestrel; Efavirenz; Etonogestrel; Nevirapine; Reverse Transcriptase Inhibitors

Criteria

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

• Display willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

• Age between 18 and 45 years and female sex

• Diagnosis of HIV-1 infection

• Desiring ENG subdermal implant as a contraceptive method

• Participants not yet eligible for ART (based on the Ugandan Treatment Guidelines); or participants receiving NVP or EFV-based ART for a minimum of 1 month prior to screening

• Participants on EFV-based ART must have an alternative form on effective non-hormonal contraception, such as surgical sterilization or copper intrauterine device in place

Exclusion Criteria:

• For potential participants on ART: HIV-1 RNA > 400 copies/mL at screening visit

• Serum hemoglobin < 9.0 g/dl

• Elevations in serum levels of alanine transaminase (ALT) 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 ENG, NVP (for women taking NVP-based ART), or EFV (for women taking EFV-based ART) 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 based on the US Department of Health and Human Services drug interaction table.

• Currently pregnant or postpartum <30 days at study entry. Participants must have a negative urine pregnancy test and report no unprotected sex since the last menstrual period or in the last two weeks.

• Concurrent use of other hormonal contraception (Note: use of other forms of hormonal contraception is permissible until time of study enrollment/insertion of ENG implant. Transition from other forms of hormonal contraception to ENG subdermal implant will be accommodated according to ENG product labeling.)