Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception

University of Pittsburgh

Status

Completed

Conditions

HIV

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02375425

PRO14090571

Details and patient eligibility

About

The development of surrogates to predict HIV prevention product safety and efficacy is a high priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed to rectally applied microbicides in vivo and then challenged with HIV in the lab showed significant reduction in HIV replication when compared to tissue exposed to placebo gel. Currently, the ex vivo challenge model for ectocervical and vaginal tissue is under development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA. Currently the Reproductive Infectious Disease Research Group is conducting a study designed to answer important questions about the ex vivo challenge model:which HIV virus is the best to use in the laboratory and what is the best indicator of HIV infection. The proposed study delineated here will investigate the effect of BV, HSV and contraceptive use on the model . There will be two arms to the study; the first will investigate the impact of HSV and BV status and the second, contraceptive use. Vaginal and cervical biopsies will be collected from participants for the ex vivo challenge model.

Enrollment

294 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18-45
HIV uninfected. Note: if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the enrollment visit for this trial. Otherwise, the potential participant should undergo testing at the first study visit.
Willing and able to give informed consent to take place in the study
Willing to undergo a pelvic examination and genital biopsies and HIV and HSV testing
Willing to provide contact information
Agree to be sexually abstinent for two weeks beginning one week prior to the enrollment visit

Exclusion criteria

Menopausal
Pregnant or within 90 days of last pregnancy
Hysterectomy
Use of a diaphragm, NuvaRing or spermicide for contraception
Reports a course of antibiotic therapy in the 14 days prior to enrollment
Known history of platelet disorder or bleeding disorder
Participation in another microbicide or contraceptive study or a study involving cervical and/or vaginal biopsies within one month of enrollment
Pelvic exam findings concerning for cervicitis including abnormal cervical discharge, erythema and edema
Use of any spermicide or spermicide-lubricated condom within one week of enrollment.
Use of any internal vaginal device or product with the exception of tampons within one week of enrollment
Any other condition that in the opinion of the site investigator would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives