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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
  Purpose

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 Intervention Phase
HIV
Contraception
HIV Infections
Drug: Depo Provera
Device: Copper T Intrauterine contraception device
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807625

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

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00807625     History of Changes
Other Study ID Numbers: F071227004
Study First Received: December 11, 2008
Last Updated: July 12, 2012
Health Authority: Zambia: Ministry of Health

Keywords provided by University of Alabama at Birmingham:
HIV/AIDS
Contraception
Birth control
CD4+
Viral Load
T-cell activation
B-cell activation
Hormonal
Intrauterine device
Depo Provera
Women
IUCD
treatment naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014