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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
연락처 및 위치
연구 장소
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California
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San Francisco, California, 미국, 94102
- San Francisco Dept of Hlth / AIDS Office
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Colorado
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Denver, Colorado, 미국, 80204
- Denver Dept of Public Health / HIVNET
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Illinois
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Chicago, Illinois, 미국, 60612
- Univ of Illinois Chicago / Howard Brown Hlth Ctr
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Chicago, Illinois, 미국, 60657
- Howard Brown Health Ctr / HIVNET
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Fenway Community Health Ctr / HIVNET
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New York
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Bronx, New York, 미국, 10456
- New York Blood Ctr
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New York, New York, 미국, 10016
- New York Univ Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Univ of Pennsylvania / HIVNET
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Rhode Island
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Pawtucket, Rhode Island, 미국, 02860
- Mem Hosp of Rhode Island
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Providence, Rhode Island, 미국, 02906
- Miriam Hosp
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Washington
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Seattle, Washington, 미국, 98104
- Univ of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
공동 작업자 및 조사자
수사관
- 연구 의자: Connie Celum
- 연구 의자: Susan Buchbinder
- 연구 의자: Haynes Sheppard
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .