Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
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ClinicalTrials.gov Identifier: NCT00829114 |
Recruitment Status
:
Completed
First Posted
: January 26, 2009
Last Update Posted
: October 31, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV/AIDS HIV Infections | Drug: ETHINYL ESTRADIOL AND LEVOGESTREL | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 370 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |
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
|
- Ovulation as determined by weekly blood progesterone (P) measurement [ Time Frame: 2 months ]
- Pregnancy as detected by monthly urine pregnancy testing [ Time Frame: 6 months ]
- Adverse events (AE) recording [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829114
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 |
Principal Investigator: | Kavita Nanda, MD | FHI 360 | |
Principal Investigator: | Vera Halpern, MD | FHI 360 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | FHI 360 |
ClinicalTrials.gov Identifier: | NCT00829114 History of Changes |
Other Study ID Numbers: |
10079 |
First Posted: | January 26, 2009 Key Record Dates |
Last Update Posted: | October 31, 2011 |
Last Verified: | October 2011 |
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:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Estradiol Polyestradiol phosphate Ethinyl Estradiol |
Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female |