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

The University of Alabama at Birmingham

Status and phase

Completed

Phase 2

Conditions

Contraception

HIV

HIV Infections

Treatments

Drug: Depo Provera

Device: Copper T Intrauterine contraception device

Study type

Interventional

Funder types

Other

Identifiers

NCT00807625

F071227004

Details and patient eligibility

About

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.

Full 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 study which examined the safety and acceptability of hormonal contraception and IUD among HIV-infected women. Secondary analyses from the previous study indicated that women who were assigned to the hormonal arm appeared to have faster disease progression based on death and decline in CD4+ count as compared to women assigned to the IUD arm. With the current study, investigators seek to understand potential mechanisms for the effect of hormonal contraception on hastening HIV disease progression. Enrolled women will be asked to use the assigned contraception method for a period of six months, and various indicators of disease progression will be collected at four follow-up visits after randomization.

Enrollment

66 patients

Sex

Female

Ages

16+ years old

Volunteers

No Healthy Volunteers

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