Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception (CHIC)
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.
|Genital Tract Mucosal Immunity Genital Tract Microflora||Drug: IUD placement Drug: Levonorgestrel IUD Drug: Copper T380A IUD|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract|
- %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium [ Time Frame: 2 months ]Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety
- Vaginal and Endometrial Flora [ Time Frame: 2 Months ]Changes in vaginal and endometrial flora as assessed by qualitative and quantitative culture
|Study Start Date:||November 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
No Intervention: Control-No IUD
Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Experimental: Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).Drug: Levonorgestrel IUD
Other Name: Mirena IUD
Experimental: Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).Drug: Copper T380A IUD
Other Name: ParaGard IUD
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240811
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Sharon Achilles, MD, PhD||University of Pittsburgh|