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Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception

NCT ID: NCT02375425

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Keywords

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BV, HSV contraceptive ex vivo challenge model

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No contraceptive use

BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+

no intervention

Intervention Type OTHER

no intervention-specimen collection study only

levonorgestrel IUD

BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+

no intervention

Intervention Type OTHER

no intervention-specimen collection study only

paraguard IUD

BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+

no intervention

Intervention Type OTHER

no intervention-specimen collection study only

DMPA

BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+

no intervention

Intervention Type OTHER

no intervention-specimen collection study only

Interventions

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no intervention

no intervention-specimen collection study only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18-45
2. 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.
3. Willing and able to give informed consent to take place in the study
4. Willing to undergo a pelvic examination and genital biopsies and HIV and HSV testing
5. Willing to provide contact information
6. Agree to be sexually abstinent for two weeks beginning one week prior to the enrollment visit

Exclusion Criteria

1. Menopausal
2. Pregnant or within 90 days of last pregnancy
3. Hysterectomy
4. Use of a diaphragm, NuvaRing or spermicide for contraception
5. Reports a course of antibiotic therapy in the 14 days prior to enrollment
6. Known history of platelet disorder or bleeding disorder
7. Participation in another microbicide or contraceptive study or a study involving cervical and/or vaginal biopsies within one month of enrollment
8. Pelvic exam findings concerning for cervicitis including abnormal cervical discharge, erythema and edema
9. Use of any spermicide or spermicide-lubricated condom within one week of enrollment.
10. Use of any internal vaginal device or product with the exception of tampons within one week of enrollment
11. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Katherine Bunge

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Bunge, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO14090571

Identifier Type: -

Identifier Source: org_study_id