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

FHI 360

Status and phase

Completed

Phase 4

Conditions

HIV Infections

HIV/AIDS

Treatments

Drug: ETHINYL ESTRADIOL AND LEVOGESTREL

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00829114

10079 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

370 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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