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Optimization of the ex Vivo Challenge

26. januar 2016 oppdatert av: Katherine Bunge, University of Pittsburgh

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.

Studieoversikt

Status

Fullført

Forhold

Optimization of Laboratory Procedures

Detaljert beskrivelse

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 being developed at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA. Questions which need to be addressed in order to optimize the model include which HIV virus is most appropriate to use to challenge the tissue, is qPCR a more appropriate endpoint and marker of infection, and can frozen tissue perform as well as fresh tissue in the challenge model.

In this study, we will collect vaginal and cervical biopsies to use in the optimization of laboratory procedures. We will obtain the sample(s) from healthy HIV negative women. Samples will be collected and taken to Magee-Womens Research Institute as laboratory specimens. Written consent will be obtained by an investigator or co-investigator prior to the collection of any samples.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Pennsylvania
  - Pittsburgh, Pennsylvania, Forente stater, 15213
    - Magee-Womens Hospital of UPMC

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Healthy, non-pregnant, HIV negative women

Beskrivelse

Inclusion Criteria:

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

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 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
laboratory specimens cervical biopsies vaginal biopsies blood

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
cervical biopsy Tidsramme: Day 1	Day 1
vaginal biopsy Tidsramme: Day 1	Day 1

Sekundære resultatmål

Resultatmål	Tidsramme
blood draw Tidsramme: Day 1	Day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Pittsburgh

Samarbeidspartnere

Bill and Melinda Gates Foundation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2014

Primær fullføring (Faktiske)

1. mars 2015

Studiet fullført (Faktiske)