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

Phase 2

Completed

• Conditions: HIV; Contraception; HIV Infections
• Interventions: Device: Copper T Intrauterine contraception device; Drug: Depo Provera

• Registration Number: NCT00807625
• Lead Sponsor: University of Alabama at Birmingham

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

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 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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IUCD	Copper T Intrauterine contraception device	Assigned to use a copper intrauterine device
DMPA	Depo Provera	Assigned to use Depo Provera

Primary Outcome Measures

Name	Time	Method
T-cell activation	4, 8, 12, and 24 weeks post-randomization

Secondary Outcome Measures

Name	Time	Method
CD4+ cell decline	4, 8, 12, and 24 weeks post-randomization
Cervical viral load	4, 8, 12, and 24 weeks post-randomization

Trial Locations

Locations (1)

The Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia