Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia - Full Text View

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00807625

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 II

MedlinePlus related topics: AIDS Birth Control

Drug Information available for: Medroxyprogesterone Medroxyprogesterone 17-acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia

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 ]

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

Arms	Assigned Interventions
IUCD: Active Comparator Assigned to use a copper intrauterine device	Device: Copper T Intrauterine contraception device IUCD inserted upon randomization to this study arm
DMPA: Active Comparator 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

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

Contacts

Contact: Elizabeth M. Stringer, MD

+26 0966 860 602

eli@uab.edu

Locations

Zambia
The Centre for Infectious Disease Research in Zambia	Recruiting
Lusaka, Zambia
Contact: Elizabeth M. Stringer, MD 26 0966 860 602 eli@uab.edu
Principal Investigator: Elizabeth M Stringer, MD
Sub-Investigator: Jeffrey Stringer, MD
Sub-Investigator: Hel Zdenek, PhD
Sub-Investigator: Mpundu Makasa, MD

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator:

Elizabeth M Stringer, MD

University of Alabama at Birmingham

More Information

Responsible Party:	University of Alabama at Birmingham ( Dr. Elizabeth Stringer, Principal Investigator )
Study ID Numbers:	#F07122700
Study First Received:	December 11, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00807625
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

Study placed in the following topic categories:

Virus Diseases
Medroxyprogesterone 17-Acetate
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Medroxyprogesterone
Copper
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs

Contraceptive Agents, Female
Reproductive Control Agents
Contraceptive Agents, Male
Infection
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009