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

Tracking Information
First Submitted Date ICMJE	January 16, 2009
First Posted Date ICMJE	January 26, 2009
Last Update Posted Date	October 31, 2011
Study Start Date ICMJE	March 2009
Actual Primary Completion Date	April 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 23, 2009)	Ovulation as determined by weekly blood progesterone (P) measurement [ Time Frame: 2 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00829114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 23, 2009)	Pregnancy as detected by monthly urine pregnancy testing [ Time Frame: 6 months ]; Adverse events (AE) recording [ Time Frame: 6 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
Official Title ICMJE	Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills
Brief Summary	Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	HIV/AIDS; HIV Infections
Intervention ICMJE	Drug: ETHINYL ESTRADIOL AND LEVOGESTREL; 30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Study Arms	Active Comparator: 1 ART/COC group Intervention: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL; Active Comparator: 2 COC group Intervention: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
Publications *	Nanda K, Delany-Moretlwe S, Dubé K, Lendvay A, Kwok C, Molife L, Nakubulwa S, Edward VA, Mpairwe B, Mirembe FM. Nevirapine-based antiretroviral therapy does not reduce oral contraceptive effectiveness. AIDS. 2013 Oct;27 Suppl 1:S17-25. doi: 10.1097/QAD.0000000000000050.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: January 23, 2009)	370
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	April 2011
Actual Primary Completion Date	April 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 35 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	South Africa, Uganda
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00829114
Other Study ID Numbers ICMJE	10079
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	FHI 360
Study Sponsor ICMJE	FHI 360
Collaborators ICMJE	United States Agency for International Development (USAID); Makerere University; RHRU National Office, University of Witwatersand, Johannesburg
Investigators ICMJE	Principal Investigator: Kavita Nanda, MD FHI 360 Principal Investigator: Vera Halpern, MD FHI 360
PRS Account	FHI 360
Verification Date	October 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP