Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
NCT ID: NCT00829114
Last Updated: 2011-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
370 participants
INTERVENTIONAL
2009-03-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
ART/COC group
ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
2
COC group
ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Interventions
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ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
No
Sponsors
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United States Agency for International Development (USAID)
FED
Makerere University
OTHER
RHRU National Office, University of Witwatersand, Johannesburg
UNKNOWN
FHI 360
OTHER
Responsible Party
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Principal Investigators
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Kavita Nanda, MD
Role: PRINCIPAL_INVESTIGATOR
FHI 360
Vera Halpern, MD
Role: PRINCIPAL_INVESTIGATOR
FHI 360
Locations
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, RHRU National Office, University of Witwatersand
Esselent Saint Hillbrow, Johannesburg, South Africa
Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology
Kampala, Kampala, Uganda
Countries
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References
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Nanda K, Delany-Moretlwe S, Dube 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.
Other Identifiers
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10079
Identifier Type: -
Identifier Source: org_study_id