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

HIV Infections Clinical Trial

— MSRC  

Official title:

Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807625
• Other study ID #: F071227004
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2008
• Last updated: July 12, 2012
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: July 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception
• HIV
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Zambia	The Centre for Infectious Disease Research in Zambia	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-cell activation		4, 8, 12, and 24 weeks post-randomization	No
Secondary	CD4+ cell decline		4, 8, 12, and 24 weeks post-randomization	No
Secondary	Cervical viral load		4, 8, 12, and 24 weeks post-randomization	No