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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00807625

First received: December 11, 2008

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 11, 2008

Last Updated Date

July 12, 2012

Start Date ^ICMJE

November 2008

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

T-cell activation [ Time Frame: 4, 8, 12, and 24 weeks post-randomization ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00807625 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CD4+ cell decline [ Time Frame: 4, 8, 12, and 24 weeks post-randomization ] [ Designated as safety issue: No ]
Cervical viral load [ Time Frame: 4, 8, 12, and 24 weeks post-randomization ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

HIV
Contraception
HIV Infections

Intervention ^ICMJE

Drug: Depo Provera
Depo Provera administered by injection at randomization visit and the 12-week study visit.
Device: Copper T Intrauterine contraception device
IUCD inserted upon randomization to this study arm

Other Name: ParaGuard TCu 380A

Study Arm (s)

Active Comparator: IUCD
Assigned to use a copper intrauterine device

Intervention: Device: Copper T Intrauterine contraception device
Active Comparator: DMPA
Assigned to use Depo Provera

Intervention: Drug: Depo Provera

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Zambia

Administrative Information

NCT Number ^ICMJE

NCT00807625

Other Study ID Numbers ^ICMJE

F071227004

Has Data Monitoring Committee

Responsible Party

University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Elizabeth M Stringer, MD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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