- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00013663
Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy
연구 개요
상세 설명
Step I: In addition to continuing HAART, patients are randomized into 1 of the following 4 arms:
A: Immunization placebo; B: Immunization with the canarypox HIV-vaccine (vCP1452); C: Daily low-dose IL-2 + immunization placebo; or D: Daily low-dose IL-2 + canarypox HIV-vaccine (vCP1452). Patients on Arms A, B, C, and D receive vaccine (or vaccine placebo) injections at Weeks 0, 4, 8, and 12. Patients on Arms C and D receive IL-2 by self-injection. HAART is not provided as part of this study.
Step II: Patients on all arms (A, B, C, and D) who meet inclusion criteria advance to Step II and interrupt HAART for a minimum of 12 weeks. The efficacy of these immunological therapies will be determined by monitoring the dynamics of viral rebound upon cessation of antiviral therapy. After 12 weeks of Step II, patients whose viral load remains below 30,000 copies/ml remain on Step II, off HAART, and continue weekly viral load monitoring. Patients will not terminate Step II or resume HAART unless and until their viral load increases to more than 30,000 copies/ml on 3 successive determinations, or their CD4 count decreases to less than 200 cells/mm3 or less than 50 percent of the baseline CD4+ T cell concentration on 2 successive occasions.
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10021
- New York Hosp - Cornell Med Ctr
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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:
- Are HIV-positive.
- Are more than 18 years old.
- Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months.
- Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry.
- Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry.
- Have not had virologic failure on the current HAART regimen.
- Have a negative urine pregnancy test within 14 days of entering the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a current AIDS-defining illness.
- Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml).
- Have a history of using agents affecting the immune system.
- Have active uncontrolled heart disease.
- Have had IL-2 therapy within 4 weeks of entering the study.
- Have received other treatment that affects the immune system within 4 weeks of entry.
- Have a history of a cancer requiring chemotherapy.
- Have untreated thyroid disease, within 4 weeks of entering the study.
- Have uncontrolled allergic disorders or autoimmune diseases, including asthma, inflammatory bowel disease, and psoriasis.
- Abuse substances that may interfere with the ability to follow study requirements.
- Are allergic to eggs.
- Have hepatitis B or hepatitis C.
- Are pregnant or breast-feeding.
- Work in close contact with canaries, such as a job at breeding farms or bird shops.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25 (8 to 12 weeks following HAART interruption
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2차 결과 측정
결과 측정 |
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Proportion of participants who relapse during the first 12 weeks following stopping of HAART
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length of time to the termination of Step II among participants
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changes in frequency, activation state, and HIV-specific functional capacity of T and NK cells in blood, as monitored by expression of intracellular cytokines during the first 12 weeks after stopping HAART, with respect to termination of Step II
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kendall A. Smith, MD, Division of Immunology, Department of Medicine, Weill Medical College, Cornell University
연구 기록 날짜
연구 주요 날짜
연구 완료 (실제)
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. .
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