A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1
Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1
The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.
調査の概要
状態
条件
詳細な説明
There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection.
Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.
研究の種類
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94102
- San Francisco Dept of Hlth / AIDS Office
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Colorado
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Denver、Colorado、アメリカ、80204
- Denver Dept of Public Health / HIVNET
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Illinois
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Chicago、Illinois、アメリカ、60612
- Univ of Illinois Chicago / Howard Brown Hlth Ctr
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Chicago、Illinois、アメリカ、60657
- Howard Brown Health Ctr / HIVNET
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Fenway Community Health Ctr / HIVNET
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New York
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Bronx、New York、アメリカ、10456
- New York Blood Ctr
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New York、New York、アメリカ、10016
- New York Univ Med Ctr
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Univ of Pennsylvania / HIVNET
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Rhode Island
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Pawtucket、Rhode Island、アメリカ、02860
- Mem Hosp of Rhode Island
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Providence、Rhode Island、アメリカ、02906
- Miriam Hosp
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Washington
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Seattle、Washington、アメリカ、98104
- Univ of Washington
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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
説明
Inclusion Criteria
Patients may be eligible for this study if they:
- Become infected with HIV while participating in HIVNET 014, or if they are an HIV-positive partner (sexual or needle-sharing) of a HIVNET 014A participant.
- Are able and willing to provide written informed consent.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a serious psychiatric or psychological disorder that would prevent them from completing the study.
研究計画
研究はどのように設計されていますか？
協力者と研究者
捜査官
- スタディチェア：Connie Celum
- スタディチェア：Susan Buchbinder
- スタディチェア：Haynes Sheppard
研究記録日
主要日程の研究
研究開始
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。