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

Overview

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

Full Title of Study: “Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2011

Interventions

  • Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
    • 30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
  • Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
    • 30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL

Arms, Groups and Cohorts

  • Active Comparator: 1
    • ART/COC group
  • Active Comparator: 2
    • COC group

Clinical Trial Outcome Measures

Primary Measures

  • Ovulation as determined by weekly blood progesterone (P) measurement
    • Time Frame: 2 months

Secondary Measures

  • Pregnancy as detected by monthly urine pregnancy testing
    • Time Frame: 6 months
  • Adverse events (AE) recording
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • FHI 360
  • Collaborator
    • United States Agency for International Development (USAID)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kavita Nanda, MD, Principal Investigator, FHI 360
    • Vera Halpern, MD, Principal Investigator, FHI 360

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