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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00807625
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
HIV Contraception HIV Infections Drug: Depo Provera Device: Copper T Intrauterine contraception device Phase 2

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  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia
Study Start Date : November 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

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 Name: 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.

Primary Outcome Measures :
  1. T-cell activation [ Time Frame: 4, 8, 12, and 24 weeks post-randomization ]

Secondary Outcome Measures :
  1. CD4+ cell decline [ Time Frame: 4, 8, 12, and 24 weeks post-randomization ]
  2. Cervical viral load [ Time Frame: 4, 8, 12, and 24 weeks post-randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00807625

The Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Elizabeth M Stringer, MD University of Alabama at Birmingham

Responsible Party: University of Alabama at Birmingham Identifier: NCT00807625     History of Changes
Other Study ID Numbers: F071227004
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by University of Alabama at Birmingham:
Birth control
Viral Load
T-cell activation
B-cell activation
Intrauterine device
Depo Provera
treatment naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Contraceptive Agents
Medroxyprogesterone Acetate
Reproductive Control Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral