Status:
COMPLETED
Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
HIV
Contraception
Eligibility:
FEMALE
16+ years
Phase:
PHASE2
Brief Summary
In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investi...
Detailed Description
In this randomized controlled trial, 66 HIV-infected women who desire contraception will be assigned to one of two treatment groups: IUD or Depo Provera. The study builds on findings from a previous s...
Eligibility Criteria
Inclusion
- Confirmed HIV status by local rapid test algorithm
- Willingness to be randomized to a contraceptive method and continue that method for at least 6 months.
- Intention to stay in the study area for at least 6 months
Exclusion
- Currently pregnant or pregnant within the prior 6 months
- Currently breastfeeding
- Documented liver disease
- History of coagulation disorder
- Active tuberculosis
- Anemia, defined as Hgb \<8gm/dL
- Age \< 16 years (the age of consent in Zambia);
- Eligible for antiretroviral therapy based on Zambian National Guidelines (CD4+ \< 200, or WHO stage IV, or CD4+\< 350 and WHO stage III)
- Currently using an IUD or hormonal method of contraception, or have used a hormonal contraceptive in the past 6 months
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00807625
Start Date
November 1 2008
End Date
July 1 2010
Last Update
July 13 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Centre for Infectious Disease Research in Zambia
Lusaka, Lusaka Province, Zambia