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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

December 11, 2008
July 12, 2012
November 2008
July 2010   (final data collection date for primary outcome measure)
T-cell activation [ Time Frame: 4, 8, 12, and 24 weeks post-randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00807625 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Contraception
  • HIV Infections
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Female
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT00807625
F071227004
No
University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Elizabeth M Stringer, MD University of Alabama at Birmingham
University of Alabama at Birmingham
July 2012

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