- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00001057
The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3
To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 counts greater than or equal to 550 cells/mm3.
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.
연구 개요
상세 설명
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.
Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Univ of Minnesota
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Minneapolis, Minnesota, 미국, 55415
- Hennepin County Med Clinic
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Saint Paul, Minnesota, 미국, 55101
- St Paul Ramsey Med Ctr
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Nebraska
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Omaha, Nebraska, 미국, 681985130
- Univ of Nebraska Med Ctr
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve Univ
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 191075098
- Thomas Jefferson Univ Hosp
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Texas
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Galveston, Texas, 미국, 775550435
- Univ of Texas Galveston
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antibiotics for bacterial infections as clinically indicated.
- Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively.
- Antipyretics.
- Analgesics.
- Allergy medications.
- Oral contraceptives.
- Nonprescription medications such as vitamins or herbal therapies.
Concurrent Treatment:
Allowed:
- Radiation therapy to local lesion only.
- Acupuncture.
Patients must have:
- HIV seropositivity.
- CD4 count >= 550 cells/mm3.
- No ARC or AIDS conditions by CDC criteria.
- Consent of parent or guardian if less than 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Presence of factors predisposing to pancreatitis such as active alcoholism.
- Other medical conditions that would interfere with study compliance.
Concurrent Medication:
Excluded:
- Other antiretrovirals or systemic immunomodulators.
- Systemic corticosteroids.
- Systemic cytotoxic chemotherapy.
- Intravenous pentamidine.
Concurrent Treatment:
Excluded:
- Radiation therapy except to local lesion.
Patients with the following prior conditions are excluded:
- History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month.
- History of grade 2 or worse peripheral neuropathy.
- History of pancreatitis.
- Bacterial infection requiring antibiotics within 14 days prior to study entry.
Prior Medication:
Excluded:
- Prior HIV therapy with antiretrovirals or systemic immunomodulators.
Prior Treatment:
Excluded within 2 weeks prior to study entry:
- Transfusion.
Active substance abuse or alcoholism.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Carey J
- 연구 의자: Erice A
- 연구 의자: Balfour H
- 연구 의자: Henry K
- 연구 의자: Hasse A
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACTG 275
- 11251 (레지스트리 식별자: DAIDS ES Registry Number)
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. .
HIV 감염에 대한 임상 시험
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Hospital Clinic of Barcelona완전한
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University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation완전한파트너 HIV 테스트 | 부부 에이즈 상담 | 커플커뮤니케이션 | HIV 발병률카메룬, 도미니카 공화국, 그루지야, 인도
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Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS), Ministério da... 그리고 다른 협력자들모집하지 않고 적극적으로HIV, 신생아 HIV 조기 진단(EID), 현장 진료 검사(PoC)모잠비크, 탄자니아
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
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Erasmus Medical Center모병
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Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
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Erasmus Medical Center아직 모집하지 않음
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Erasmus Medical Center모집하지 않고 적극적으로
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University of Maryland, BaltimoreNational Institute of Mental Health (NIMH); Albert Einstein College of Medicine; Yale University 그리고 다른 협력자들아직 모집하지 않음HIV 예방 | HIV 사전 노출 예방
지도부딘에 대한 임상 시험
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University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID); University of Hawaii완전한
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Assistance Publique - Hôpitaux de Paris완전한
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Obafemi Awolowo UniversityLondon School of Hygiene and Tropical Medicine; University of California, San Diego; University... 그리고 다른 협력자들완전한
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Harvard School of Public Health (HSPH)National Institute of Allergy and Infectious Diseases (NIAID)종료됨