Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.

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

Details

• Lead Sponsor: FHI 360
• Collaborators: Makerere University; RHRU National Office, University of Witwatersand, Johannesburg; United States Agency for International Development (USAID)
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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