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

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

Official Title
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Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills

Conditions
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HIV/AIDS, HIV Infections

Intervention / Treatment
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* Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
* Drug: ETHINYL ESTRADIOL AND LEVOGESTREL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ART/COC group | Drug: ETHINYL ESTRADIOL AND LEVOGESTREL<br>* 30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL<br>|
| Active Comparator: 2<br>COC group | Drug: ETHINYL ESTRADIOL AND LEVOGESTREL<br>* 30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation as determined by weekly blood progesterone (P) measurement |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy as detected by monthly urine pregnancy testing |  | 6 months | 
| Adverse events (AE) recording |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AE, AIDS, ALT, ART, AST, DCF, DMC, FDA, GCP, HB sAg, ICH, IND, IRB, IU, mg, mm3, PCR, SAE, ULN, WB, COC, Combined Oral Contraceptives