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

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Makerere University
RHRU National Office, University of Witwatersand, Johannesburg
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT00829114
First received: January 16, 2009
Last updated: October 28, 2011
Last verified: October 2011
History of Changes

January 16, 2009
October 28, 2011
March 2009
April 2011   (final data collection date for primary outcome measure)
Ovulation as determined by weekly blood progesterone (P) measurement [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829114 on ClinicalTrials.gov Archive Site
  • Pregnancy as detected by monthly urine pregnancy testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adverse events (AE) recording [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills

Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV/AIDS
  • HIV Infections
Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
  • Active Comparator: 1
    ART/COC group
    Intervention: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
  • Active Comparator: 2
    COC group
    Intervention: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Uganda
 
NCT00829114
10079
No
FHI 360
FHI 360
  • United States Agency for International Development (USAID)
  • Makerere University
  • RHRU National Office, University of Witwatersand, Johannesburg
Principal Investigator: Kavita Nanda, MD FHI 360
Principal Investigator: Vera Halpern, MD FHI 360
FHI 360
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP