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

Purpose

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

Condition	Intervention	Phase
HIV/AIDS HIV Infections	Drug: ETHINYL ESTRADIOL AND LEVOGESTREL	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions HIV/AIDS

Drug Information available for: Estradiol Ethinyl Estradiol Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

Further study details as provided by FHI 360:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	370
Study Start Date:	March 2009
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829114

Locations


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

Sponsors and Collaborators

FHI 360

United States Agency for International Development (USAID)

Makerere University

RHRU National Office, University of Witwatersand, Johannesburg

Investigators


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

More Information

No publications provided by FHI 360

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	FHI 360
ClinicalTrials.gov Identifier:	NCT00829114 History of Changes
Other Study ID Numbers:	10079
Study First Received:	January 16, 2009
Last Updated:	October 28, 2011
Health Authority:	United States: Institutional Review Board South Africa: National Health Research Ethics Council Uganda: Research Ethics Committee

Keywords provided by FHI 360:


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

Additional relevant MeSH terms:


Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined Estradiol Estradiol 17 beta-cypionate Estradiol 3-benzoate Estradiol valerate Ethinyl Estradiol Polyestradiol phosphate	Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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