Status:
COMPLETED
Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women
Lead Sponsor:
Catherine Anne Chappell
Collaborating Sponsors:
Infectious Disease Institute, Kampala, Uganda
University of Nebraska
Conditions:
HIV/AIDS
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
This study will evaluate the frequency of ovulation and cervical mucus quality of HIV-infected Ugandan women on efavirenz-based antiretroviral therapy using either a single etonogestrel implant or two...
Detailed Description
This study is being done to compare the rate of ovulation when women receive two subdermal implant contraception devices containing the hormone etonogestrel (instead of only one device) while taking t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03282799
Start Date
February 19 2019
End Date
October 25 2022
Last Update
September 5 2024
Active Locations (1)
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1
Infectious Disease Institute
Kampala, Uganda