NCT02134535

Completed

Optimization of the ex Vivo Challenge

University of Pittsburgh Source

Other study identifiers

Sponsor study identifier

PRO13120447

Study Type

observational

Actual enrollment (reported)

73

Locations

1 country

Sites

1

Timeline

Study Start

May 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2015

Actual (reported)

Study Completion

March 2015

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 73 participants
Study completion date: March 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 7, 2014
Actual (reported)
First Posted
May 9, 2014
Actual (reported)
Primary Completion
March 2015
Actual (reported)
Study Completion
March 2015
Actual (reported)

Last Updated: January 27, 2016
Status Verified: January 2016
Last Update Submitted: January 26, 2016

Conditions

Optimization of Laboratory Procedures

Outcome Measures

Primary Outcomes (2)

cervical biopsy
Day 1
vaginal biopsy
Day 1

Secondary Outcomes (1)

blood draw
Day 1

Study Arms (1)

laboratory specimens

cervical biopsies vaginal biopsies blood

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Healthy, non-pregnant, HIV negative women

You may qualify if:

Age 18-45

Sponsors & Collaborators

Bill and Melinda Gates Foundation
Othercollaborator
University of Pittsburgh
Otherlead

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Study Officials

Katherine Bunge, MD
University of Pittsburgh
PRINCIPAL INVESTIGATOR

Enrollment

73 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 9, 2014

Study Start

May 2014

Date type not reported

This date has not been verified as actual or estimated.

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

Contact the study team to confirm eligibility.

Primary Completion

March 2015

Actual (reported)

Study Completion

March 2015

Actual (reported)

Last Updated

January 27, 2016

Record last verified: 2016-01

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT02134535
Data provider: ClinicalTrials.gov
Source updated: 2016-01-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:24 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

laboratory specimens

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations