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

HIV Infections Clinical Trial

Official title:

Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829114
• Other study ID #: 10079
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2009
• Last updated: October 28, 2011
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2011
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSouth Africa: National Health Research Ethics CouncilUganda: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV/AIDS

Intervention

Drug:
• 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

Locations

Country	Name	City	State
South Africa	, RHRU National Office, University of Witwatersand	Esselent St. Hillbrow	Johannesburg
Uganda	Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
FHI 360	Makerere University, RHRU National Office, University of Witwatersand, Johannesburg, United States Agency for International Development (USAID)

Countries where clinical trial is conducted

South Africa,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation as determined by weekly blood progesterone (P) measurement		2 months	No
Secondary	Pregnancy as detected by monthly urine pregnancy testing		6 months	No
Secondary	Adverse events (AE) recording		6 months	No