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

July 12, 2012 updated by: University of Alabama at Birmingham

Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • The Centre for Infectious Disease Research in Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: IUCD
Assigned to use a copper intrauterine device
Device: Copper T Intrauterine contraception device
IUCD inserted upon randomization to this study arm
Other Names:
  • ParaGuard TCu 380A
ACTIVE_COMPARATOR: DMPA
Assigned to use Depo Provera
Drug: Depo Provera
Depo Provera administered by injection at randomization visit and the 12-week study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
T-cell activation
Time Frame: 4, 8, 12, and 24 weeks post-randomization
4, 8, 12, and 24 weeks post-randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
CD4+ cell decline
Time Frame: 4, 8, 12, and 24 weeks post-randomization
4, 8, 12, and 24 weeks post-randomization
Cervical viral load
Time Frame: 4, 8, 12, and 24 weeks post-randomization
4, 8, 12, and 24 weeks post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Elizabeth M Stringer, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

December 11, 2008

First Submitted That Met QC Criteria

December 11, 2008

First Posted (ESTIMATE)

December 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F071227004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Copper T Intrauterine contraception device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe