drugset / Trial / NCT01240811

Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception

NCT01240811

Completed 42 enrolled Sharon Achilles
RandomizedParallel-groupOpen-labelBasic science

Summary

This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors). Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives. The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.

Timeline

Start
2010-11
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Levonorgestrel Small molecule

Indications

No indication recorded.