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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
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

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

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

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. Ovulation as determined by weekly blood progesterone (P) measurement [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Pregnancy as detected by monthly urine pregnancy testing [ Time Frame: 6 months ]
  2. Adverse events (AE) recording [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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