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

NCT00807625 | Completed Phase 2

• 1 other identifier: F071227004
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• T-cell activation

  4, 8, 12, and 24 weeks post-randomization

Secondary Outcomes (2)

• CD4+ cell decline

  4, 8, 12, and 24 weeks post-randomization

• Cervical viral load

  4, 8, 12, and 24 weeks post-randomization

Study Arms (2)

IUCD

ACTIVE COMPARATOR

Assigned to use a copper intrauterine device

Device: Copper T Intrauterine contraception device

DMPA

ACTIVE COMPARATOR

Assigned to use Depo Provera

Drug: Depo Provera

Interventions

Depo Provera DRUG

Depo Provera administered by injection at randomization visit and the 12-week study visit.

DMPA

Copper T Intrauterine contraception device DEVICE

IUCD inserted upon randomization to this study arm

Also known as: ParaGuard TCu 380A

IUCD

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The Centre for Infectious Disease Research in Zambia

Lusaka, Lusaka Province, Zambia

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Elizabeth M Stringer, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

ZA (1)