Optimization of the ex Vivo Challenge

Completed

Conditions studied: Optimization of Laboratory Procedures

In brief

The overall purpose of this research study is to collect vaginal and cervical biopsies from healthy HIV negative participants. These samples will enable investigators to optimize laboratory methods and explore implementation challenges associated with the ex vivo challenge model. The first objective is to assess which HIV virus is best for use in the model. The second objective is to determine the best endpoint for the assay. The primary aim of this study is to collect an adequate number of cervical and vaginal biopsies to support the optimization of an ex vivo challenge model. This ex vivo challenge model has been and will continue to be used in topical microbicide clinical trials to predict the efficacy of candidate drugs.

Key facts

Study ID

NCT02134535

Run by

University of Pittsburgh

People needed

73

Starts

2014-05-01

Expected to finish

2015-03-01

Last updated by the study team

2016-01-27

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age 18-45
• Free from abnormal vaginal discharge or other current vaginal symptoms
• HIV uninfected. Note: if a woman recently 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 under go 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
• Willing to provide contact information
• Agree to be sexually abstinent for two weeks beginning one week prior to the enrollment visit

You may not qualify if…

• 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 coagulapathy.
• Participation in another microbicide or contraceptive study or a study involving cervical and/or vaginal biopsies within one month of enrollment
• 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

Where it is running

• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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