HIV/AIDS, HIV Infections
Conditions
Keywords
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
Brief summary
Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
Interventions
DRUGETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Sponsors
United States Agency for International Development (USAID)
Makerere University
RHRU National Office, University of Witwatersand, Johannesburg
FHI 360
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ovulation as determined by weekly blood progesterone (P) measurement | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy as detected by monthly urine pregnancy testing | 6 months |
| Adverse events (AE) recording | 6 months |
Countries
South Africa, Uganda
Outcome results
None listed