Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia
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.
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Depo Provera, Copper T Intrauterine contraception device
The Centre for Infectious Disease Research in Zambia
Active, not recruiting
University of Alabama at Birmingham
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00807625
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Intrauterine Device Migration
The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.
Intrauterine Devices, Copper
Intrauterine contraceptive devices that depend on the release of metallic copper.
Intrauterine Device Expulsion
Spontaneous loss of INTRAUTERINE DEVICES from the UTERUS.
Contraceptive devices placed high in the uterine fundus with a string extending from the device through the cervical as into the vagina. (UMDNS, 1999)
Methods of contraception in which physical, chemical, or biological means are used to prevent the SPERM from reaching the fertilizable OVUM.
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