- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00002388
A Study of 1592U89 in HIV-Infected Patients
A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects
연구 개요
상세 설명
Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.
On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
연구 유형
등록
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Illinois
-
Evanston, Illinois, 미국, 60201
- Evanston Hosp / Clinical Pharmacology Unit
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Fenway Community Health Ctr / Research Dept
-
-
New York
-
Albany, New York, 미국, 12208
- Albany Med College / Albany Med Ctr Hosp
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
Concurrent Medication:
Allowed:
Prophylaxis for opportunistic infections.
Patients must have:
- HIV-1 infection.
- CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
- No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
- Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.
Concurrent Medication:
Excluded:
- Immunomodulating agents.
- Chemotherapeutic agents.
- Antiretroviral therapy. NOTE:
- Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior conditions are excluded:
- History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
- History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
Prior Medication:
Excluded:
- Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
- Antiretroviral therapy within 2 weeks prior to administration of study drugs.
Prior Treatment:
Excluded:
Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
스폰서
연구 기록 날짜
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 238G
- CNAA1004
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
-
Hospital Clinic of Barcelona완전한
-
CDC FoundationGilead Sciences알려지지 않은
-
University of WashingtonNational Institute of Mental Health (NIMH)모병
-
University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
-
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
-
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
-
Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
Erasmus Medical Center모병
-
Erasmus Medical Center모집하지 않고 적극적으로
아바카비르 설페이트에 대한 임상 시험
-
Government of Punjab, Specialized Healthcare and...Services Hospital, Lahore; Mayo Hospital Lahore; Pakistan Kidney and Liver Institute종료됨
-
Government of Punjab, Specialized Healthcare and...Harvard School of Public Health (HSPH); Forman Christian College, Pakistan; Services Institute... 그리고 다른 협력자들종료됨코로나바이러스감염증-19 : 코로나19 | 코로나바이러스 감염 | 사스 코로나바이러스 2 | 무증상 상태파키스탄
-
Intech Biopharm Ltd.모병
-
First Affiliated Hospital of Harbin Medical University알려지지 않은
-
Tan Tock Seng HospitalNetherlands: Ministry of Health, Welfare and Sports; Duke-NUS Graduate Medical School; Singapore... 그리고 다른 협력자들빼는코로나바이러스 감염 | 하이드록시클로로퀸 부작용
-
Acrotech Biopharma Inc.National Cancer Institute (NCI)완전한