- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00006144
A Study of HIV-Disease Development in Aging
A Phase II Exploratory Study Examining Immunologic and Virologic Indices in Two Age-Differentiated Cohorts of HIV-Infected Subjects to Explore the Basis of Accelerated HIV-Disease Progression Associated With Aging
The purpose of this study is to better understand the relationship between age and HIV disease progression.
This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.
연구 개요
상세 설명
Older age is an important risk factor for accelerated HIV-disease progression. However, the virologic response to highly active antiretroviral therapy (HAART) may be superior in older persons. A better understanding of the immunologic, virologic, and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease.
Patients are grouped according to age. Group A consists of patients between the ages of 13 and 30 years. Group B consists of patients age 45 years or older. All patients receive open-label lopinavir/ritonavir (LPV/RTV) plus emtricitabine (FTC) plus stavudine (d4T) for 96 [AS PER AMENDMENT 06/04/02: 192] weeks. Study visits occur at pre-entry, entry, and Weeks 4, 8, 12, 16, and 24 then every 12 weeks thereafter through Week 96 [AS PER AMENDMENT 06/04/02: Week 192]. Clinical assessments, safety laboratory tests, CD4 cell count monitoring, lymphocyte phenotyping, and HIV-1 RNA determinations are performed routinely. Blood samples are stored for further immunology and virology studies. Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s [AS PER AMENDMENT 06/04/02: Substudy A5017s has been eliminated.]
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 900331079
- USC CRS
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Palo Alto, California, 미국, 943055107
- Stanford CRS
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San Francisco, California, 미국, 941102859
- Ucsf Aids Crs
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San Jose, California, 미국, 951282699
- Santa Clara Valley Med. Ctr.
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San Mateo, California, 미국, 943055107
- San Mateo County AIDS Program
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San Rafael, California, 미국, 94903
- Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
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Colorado
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Aurora, Colorado, 미국, 80262
- University of Colorado Hospital CRS
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Florida
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Miami, Florida, 미국, 331361013
- Univ. of Miami AIDS CRS
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Hawaii
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Honolulu, Hawaii, 미국, 96816
- Univ. of Hawaii at Manoa, Leahi Hosp.
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Honolulu, Hawaii, 미국, 96816
- Queens Med. Ctr.
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University CRS
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Chicago, Illinois, 미국, 60612
- Rush Univ. Med. Ctr. ACTG CRS
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Methodist Hosp. of Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana Univ. School of Medicine, Wishard Memorial
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Indianapolis, Indiana, 미국, 462025250
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Adult AIDS CRS
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital ACTG CRS
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Boston, Massachusetts, 미국, 02118
- Bmc Actg Crs
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Boston, Massachusetts, 미국, 02215
- Brigham and Women's Hosp. ACTG CRS
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Boston, Massachusetts, 미국
- Beth Israel Deaconess Med. Ctr., ACTG CRS
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Fall River, Massachusetts, 미국
- SSTAR, Family Healthcare Ctr.
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota, ACTU
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Missouri
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Saint Louis, Missouri, 미국
- Washington U CRS
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New York
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New York, New York, 미국, 10003
- Beth Israel Med. Ctr., ACTU
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New York, New York, 미국, 10016
- NY Univ. HIV/AIDS CRS
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New York, New York, 미국, 10029
- Mt. Sinai Med. Ctr. A0404 CRS
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New York, New York, 미국
- Columbia Univ., HIV Prevention and Treatment Medical Ctr.
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New York, New York, 미국
- Mt.Sinai Med. Ctr. A1009 CRS
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Rochester, New York, 미국, 14642
- Univ. of Rochester ACTG CRS
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Rochester, New York, 미국, 14642
- AIDS Care CRS
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Rochester, New York, 미국, 14607
- Trillium Health ACTG CRS
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North Carolina
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Chapel Hill, North Carolina, 미국, 275997215
- Unc Aids Crs
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Durham, North Carolina, 미국, 27710
- Duke Univ. Med. Ctr. Adult CRS
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case CRS
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Cleveland, Ohio, 미국, 441091998
- MetroHealth CRS
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Columbus, Ohio, 미국, 432101228
- The Ohio State University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Hosp. of the Univ. of Pennsylvania CRS
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Philadelphia, Pennsylvania, 미국, 19104
- Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- The Miriam Hosp. ACTG CRS
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Providence, Rhode Island, 미국
- Rhode Island Hosp.
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Tennessee
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Nashville, Tennessee, 미국
- Vanderbilt Therapeutics CRS
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Texas
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Dallas, Texas, 미국, 75235-9173
- Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
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Galveston, Texas, 미국, 77555-0435
- Univ. of Texas Medical Branch, ACTU
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Washington
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Seattle, Washington, 미국, 98104
- University of Washington AIDS CRS
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San Juan, 푸에르토 리코, 009365067
- Puerto Rico-AIDS CRS
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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 between 13 and 30 years old (need consent of parent or guardian if under 18), or are more than 44 years of age.
- Have a viral load of more than 2000 copies/ml within 60 days of study entry.
- Have a CD4 cell count of less than 600 cells/mm3 within 60 days of study entry. (This reflects a change in the CD4 cell count requirement.)
- Agree to use effective methods of birth control (such as condoms) during and for 12 weeks after the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have an AIDS-related cancer (except Kaposi's sarcoma) requiring chemotherapy.
- Have hepatitis within 30 days of study entry.
- Have diarrhea (more than 3 liquid stools/day for at least 14 days) within 30 days of study entry.
- Are receiving chemotherapy or radiation treatment.
- Have taken antiretroviral drugs for more than 14 days.
- Have received an HIV vaccine within 30 days of study.
- Have a serious illness or infection within 14 days of the study.
- Have other serious conditions that might interfere with study participation.
- Have taken or plan to take certain other drugs that might affect the study results.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Robert Kalayjian
간행물 및 유용한 링크
일반 간행물
- Tenorio AR, Spritzler J, Martinson J, Gichinga CN, Pollard RB, Lederman MM, Kalayjian RC, Landay AL. The effect of aging on T-regulatory cell frequency in HIV infection. Clin Immunol. 2009 Mar;130(3):298-303. doi: 10.1016/j.clim.2008.10.001. Epub 2008 Nov 12.
- Kalayjian R, Landay A, Pollard R, Pu M, Spritzer J, Tebas P, Gross B, Valcour V, Cu-Uvin S, Fiscus S, Fidel P, Wu A, Fox L, Stocker V, Lederman M, and AIDS Clinical Trials Group Protocol 5015. ACTG 5015: NaIve T-cell Reconstitution is Associated with Immune Activation. CROI 2004. Abstract 232.
연구 기록 날짜
연구 주요 날짜
연구 시작
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
- 병리학적 과정
- RNA 바이러스 감염
- 바이러스 질환
- 감염
- 혈액 매개 감염
- 전염병
- 성병, 바이러스성
- 성병
- 렌티바이러스 감염
- 레트로바이러스과 감염
- 면역 결핍 증후군
- 면역계 질환
- 질병 속성
- 느린 바이러스 질환
- HIV 감염
- 질병 진행
- 후천성면역결핍증후군
- 약리작용의 분자기전
- 항감염제
- 항바이러스제
- 역전사 효소 억제제
- 핵산 합성 억제제
- 효소 억제제
- 항HIV제
- 항레트로바이러스제
- 항대사물질
- 프로테아제 억제제
- 시토크롬 P-450 CYP3A 억제제
- 시토크롬 P-450 효소 억제제
- HIV 프로테아제 억제제
- 바이러스성 프로테아제 억제제
- 엠트리시타빈
- 리토나비어
- 로피나비르
- 스타부딘
기타 연구 ID 번호
- A5015
- 10168 (레지스트리 식별자: DAIDS ES)
- ACTG A5015
- AACTG A5015
- Substudy ACTG A5016s
- Substudy ACTG A5020s
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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