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

October 28, 2011 updated by: FHI 360

Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

370

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Johannesburg
      • Esselent St. Hillbrow, Johannesburg, South Africa, 2001
        • , RHRU National Office, University of Witwatersand
  • Uganda
      • Kampala, Uganda
        • Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
ART/COC group
Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Active Comparator: 2
COC group
Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Collaborators

United States Agency for International Development (USAID)
Makerere University
RHRU National Office, University of Witwatersand, Johannesburg

Investigators

  • Principal Investigator: Vera Halpern, MD, FHI 360
  • Principal Investigator: Kavita Nanda, MD, FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

October 31, 2011

Last Update Submitted That Met QC Criteria

October 28, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10079 (Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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