Status:
COMPLETED
Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
Lead Sponsor:
FHI 360
Collaborating Sponsors:
United States Agency for International Development (USAID)
Makerere University
Conditions:
HIV/AIDS
HIV Infections
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief Summary
Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
Eligibility Criteria
Inclusion
- Willing to provide informed consent
- Willing to take COCs and follow all study requirements
- Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)
- Last menstrual period (LMP) \<35 days before study entry
- Has body mass index of 18-30
- Negative urine pregnancy test as enrollment
- Documented HIV-1 infection
- On nevirapine-containing ART for at least three months (ART group only)
- CD4 cell count of greater than or equal to 350 (for non-ARV group only)
- Currently sexually active and plans to stay sexually active for the next 6 months
Exclusion
- Medical contraindications to COC use
- Recent pregnancy (within 3 months)
- Has breastfed in last 3 months
- Last pregnancy was ectpoic
- Has been sterilized
- Has had any of the following conditions since last pregnancy, or since menarche if never pregnant:
- Pelvic Inflammatory disease Diagnosis of infertility
- Has had DMPA within 6 months or NET injectable within 3 months of study entry (or has had no menses since last injection regardless of its timing)
- has taken other hormonal therapies besides COCs (e.g., combined injectables, progestin implants or intrauterine systems, progestin-only contraceptive pills, medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study entry
- Has an acute infection or other opportunistic diseases requiring therapy within 14 days before enrollment
- Has active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
- Has taken any prohibited medication within 30 days before study entry
- Has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake
- Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00829114
Start Date
March 1 2009
End Date
April 1 2011
Last Update
October 31 2011
Active Locations (2)
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1
, RHRU National Office, University of Witwatersand
Esselent Saint Hillbrow, Johannesburg, South Africa, 2001
2
Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology
Kampala, Kampala, Uganda