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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No contraceptive use | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
| |
| levonorgestrel IUD | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
| |
| paraguard IUD | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
| |
| DMPA | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention-specimen collection study only |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV infection of cervical and vaginal biopsies as measured by HIV-1 p24 replication by ELISA or by qPCR for HIV provirus | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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non-pregnant, HIV negative, healthy 18-45 year old women
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Bunge, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |