Clinical trial NCT00829114: Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
Official title: Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV/AIDS
HIV Infections
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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Makerere University
name: RHRU National Office, University of Witwatersand, Johannesburg
First posted: 2009-01-26
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Ovulation as determined by weekly blood progesterone (P) measurement
timeFrame: 2 months
Secondary outcomes:
measure: Pregnancy as detected by monthly urine pregnancy testing
timeFrame: 6 months
measure: Adverse events (AE) recording
timeFrame: 6 months
Other outcomes:
Locations:
city: Esselent St. Hillbrow
country: South Africa
facility: , RHRU National Office, University of Witwatersand
state: Johannesburg
city: Kampala
country: Uganda
facility: Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology
Study officials:
affiliation: FHI 360
name: Kavita Nanda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360
name: Vera Halpern, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.