Optimization of the ex Vivo Challenge
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- Magee-Womens Hospital of UPMC
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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laboratory specimens
cervical biopsies vaginal biopsies blood
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
cervical biopsy
時間枠:Day 1
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Day 1
|
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vaginal biopsy
時間枠:Day 1
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Day 1
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
blood draw
時間枠:Day 1
|
Day 1
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PRO13120447
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