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

NCT ID: NCT00807625

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-07-31

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.

Conditions

HIV; Contraception; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IUCD

Assigned to use a copper intrauterine device

Group Type: ACTIVE_COMPARATOR

Copper T Intrauterine contraception device

Intervention Type: DEVICE

IUCD inserted upon randomization to this study arm

DMPA

Assigned to use Depo Provera

Group Type: ACTIVE_COMPARATOR

Depo Provera

Intervention Type: DRUG

Depo Provera administered by injection at randomization visit and the 12-week study visit.

Interventions

Depo Provera

Depo Provera administered by injection at randomization visit and the 12-week study visit.

Intervention Type: DRUG

Copper T Intrauterine contraception device

IUCD inserted upon randomization to this study arm

Intervention Type: DEVICE

Other Intervention Names

ParaGuard TCu 380A

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth M Stringer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

The Centre for Infectious Disease Research in Zambia

Lusaka, Lusaka Province, Zambia

Countries

Zambia

Other Identifiers

F071227004

Identifier Type: -

Identifier Source: org_study_id