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

Primary Purpose

HIV, Contraception, HIV Infections

Status
Completed
Phase
Phase 2
Locations
Zambia
Study Type
Interventional
Intervention
Depo Provera
Copper T Intrauterine contraception device
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV/AIDS, Contraception, Birth control, CD4+, Viral Load, T-cell activation, B-cell activation, Hormonal, Intrauterine device, Depo Provera, Women, IUCD, treatment naive

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • The Centre for Infectious Disease Research in Zambia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IUCD

DMPA

Arm Description

Assigned to use a copper intrauterine device

Assigned to use Depo Provera

Outcomes

Primary Outcome Measures

T-cell activation

Secondary Outcome Measures

CD4+ cell decline
Cervical viral load

Full Information

First Posted
December 11, 2008
Last Updated
July 12, 2012
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00807625
Brief Title
Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia
Acronym
MSRC
Official Title
Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Contraception, HIV Infections
Keywords
HIV/AIDS, Contraception, Birth control, CD4+, Viral Load, T-cell activation, B-cell activation, Hormonal, Intrauterine device, Depo Provera, Women, IUCD, treatment naive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IUCD
Arm Type
Active Comparator
Arm Description
Assigned to use a copper intrauterine device
Arm Title
DMPA
Arm Type
Active Comparator
Arm Description
Assigned to use Depo Provera
Intervention Type
Drug
Intervention Name(s)
Depo Provera
Intervention Description
Depo Provera administered by injection at randomization visit and the 12-week study visit.
Intervention Type
Device
Intervention Name(s)
Copper T Intrauterine contraception device
Other Intervention Name(s)
ParaGuard TCu 380A
Intervention Description
IUCD inserted upon randomization to this study arm
Primary Outcome Measure Information:
Title
T-cell activation
Time Frame
4, 8, 12, and 24 weeks post-randomization
Secondary Outcome Measure Information:
Title
CD4+ cell decline
Time Frame
4, 8, 12, and 24 weeks post-randomization
Title
Cervical viral load
Time Frame
4, 8, 12, and 24 weeks post-randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth M Stringer, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Centre for Infectious Disease Research in Zambia
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

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

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