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

This study has been completed.

Sponsor:

Collaborators:

United States Agency for International Development (USAID)

Makerere University

RHRU National Office, University of Witwatersand, Johannesburg

Information provided by (Responsible Party):

FHI 360

ClinicalTrials.gov Identifier:

NCT00829114

First received: January 16, 2009

Last updated: October 28, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 16, 2009

Last Updated Date

October 28, 2011

Start Date ^ICMJE

March 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ovulation as determined by weekly blood progesterone (P) measurement [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00829114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pregnancy as detected by monthly urine pregnancy testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Adverse events (AE) recording [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

HIV/AIDS
HIV Infections

Intervention ^ICMJE

Drug: ETHINYL ESTRADIOL AND LEVOGESTREL

30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL

Study Arm (s)

Active Comparator: 1
ART/COC group

Intervention: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
Active Comparator: 2
COC group

Intervention: Drug: ETHINYL ESTRADIOL AND LEVOGESTREL

Publications *

Nanda K, Delany-Moretlwe S, Dubé 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

370

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

South Africa, Uganda

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00829114

Other Study ID Numbers ^ICMJE

10079

Has Data Monitoring Committee

Responsible Party

FHI 360

Study Sponsor ^ICMJE

FHI 360

Collaborators ^ICMJE

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

Investigators ^ICMJE

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

Information Provided By

FHI 360

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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