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

Primary Purpose

HIV/AIDS, HIV Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ETHINYL ESTRADIOL AND LEVOGESTREL
ETHINYL ESTRADIOL AND LEVOGESTREL
Sponsored by
FHI 360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring 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

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • , RHRU National Office, University of Witwatersand
  • Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

ART/COC group

COC group

Outcomes

Primary Outcome Measures

Ovulation as determined by weekly blood progesterone (P) measurement

Secondary Outcome Measures

Pregnancy as detected by monthly urine pregnancy testing
Adverse events (AE) recording

Full Information

First Posted
January 16, 2009
Last Updated
October 28, 2011
Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID), Makerere University, RHRU National Office, University of Witwatersand, Johannesburg
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1. Study Identification

Unique Protocol Identification Number
NCT00829114
Brief Title
Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
Official Title
Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID), Makerere University, RHRU National Office, University of Witwatersand, Johannesburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HIV Infections
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
ART/COC group
Arm Title
2
Arm Type
Active Comparator
Arm Description
COC group
Intervention Type
Drug
Intervention Name(s)
ETHINYL ESTRADIOL AND LEVOGESTREL
Intervention Description
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Intervention Type
Drug
Intervention Name(s)
ETHINYL ESTRADIOL AND LEVOGESTREL
Intervention Description
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Primary Outcome Measure Information:
Title
Ovulation as determined by weekly blood progesterone (P) measurement
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Pregnancy as detected by monthly urine pregnancy testing
Time Frame
6 months
Title
Adverse events (AE) recording
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kavita Nanda, MD
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vera Halpern, MD
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
Facility Information:
Facility Name
, RHRU National Office, University of Witwatersand
City
Esselent St. Hillbrow
State/Province
Johannesburg
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Makerere University Medical School, Mulago Hospital, Department of Obstetrics and Gynecology
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
24088680
Citation
Nanda K, Delany-Moretlwe S, Dube 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.
Results Reference
derived

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

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