Clinical trial NCT00807625: Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia
Official title: Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-12-12
Enrollment: 66
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: T-cell activation
timeFrame: 4, 8, 12, and 24 weeks post-randomization
Secondary outcomes:
measure: CD4+ cell decline
timeFrame: 4, 8, 12, and 24 weeks post-randomization
measure: Cervical viral load
timeFrame: 4, 8, 12, and 24 weeks post-randomization
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: The Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: University of Alabama at Birmingham
name: Elizabeth M Stringer, MD
role: PRINCIPAL_INVESTIGATOR
References: