Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

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 investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Contraceptive Agents; Copper; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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