- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00027352
항 HIV 치료를 관리하는 두 가지 방법 비교(SMART 연구)
항레트로바이러스 요법의 관리를 위한 두 가지 전략을 비교하는 대규모의 간단한 시험(SMART 연구)
연구 개요
상태
정황
상세 설명
HIV에 감염된 개인의 대다수에 대한 바이러스 부하의 최대 및 지속적인 억제를 강조하는 항레트로바이러스 치료(ART) 지침의 구현으로 이환율과 사망률이 크게 감소했습니다. 그러나 많은 무증상 환자는 심각한 기회 질병의 즉각적인 위험에 처하지 않으며, ART의 효과는 HIV 약물 내성으로 인해 시간이 지남에 따라 약해지고 단기 및 장기 치료 독성이 있습니다. 이것은 두 가지 전략을 비교하도록 동기를 부여합니다. 하나는 기회 질병의 위험이 낮으면서 사용을 연기하여 치료를 보존하는 것이고 다른 하나는 질병 위험과 관계없이 지속적인 바이러스 억제를 목표로 합니다.
이 대규모 장기 시험에서 환자는 약물 보존(DC) 또는 바이러스 억제(VS) 그룹에 무작위로 배정됩니다. 환자는 3년 동안 등록되며 평균 7.5년 동안 추적됩니다. DC 그룹은 CD4 세포 수가 250 세포/mm3 미만으로 감소할 때까지 ART를 중단하거나 연기합니다. 그런 다음 CD4 수를 350개 세포/mm3 이상으로 증가시키는 치료를 받은 후 CD4 세포 수를 기반으로 하는 간헐적 ART를 받게 됩니다. VS 그룹은 ART를 사용하여 CD4 세포 수에 관계없이 바이러스 부하를 가능한 한 낮게 유지합니다. 환자는 1, 2, 4, 6, 8, 10, 12개월에 진료를 받고 데이터 수집 방문을 위해 4개월마다 진료를 받게 됩니다. 면역 조절제를 포함하여 사용 가능한 모든 ART 및 저항성 검사는 두 치료 그룹의 환자가 사용할 수 있습니다. 연구에 등록된 환자의 선택된 하위 샘플은 비용 및 건강 관리 이용, 삶의 질, HIV 전염 위험 행동 및 치료의 대사 합병증과 관련된 2차 결과에 대한 보다 집중적인 데이터 수집에 뒤따를 것입니다.
연구 유형
등록
연락처 및 위치
연구 장소
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Oslo, 노르웨이, N-0407
- Ullevål Hospital
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Christchurch, 뉴질랜드
- Christchurch Hosp
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Wellington, 뉴질랜드
- Wellington Hosp
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Essen, 독일, 45122
- Klinik fur Dermatologie, Venerologie, Allergologie
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Frankfort, 독일, 60590
- Johann Wolfgang Goethe University Hospital
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Heidelberg, 독일, D-69115
- Klinikum der Ruprecht-Karis-Universitat (U. Hospital)
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Zurich Ch-, 독일, 8091
- University Hospital Zürich
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-
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Barble, 룩셈부르크, L-1210
- Centre Hospitalier de Luxembourg
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Vilnius, 리투아니아, 03011
- Lithuanian AIDS center
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Fort-de-france, 마르티니크, 97261
- C.H.U. Fort-de-France
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California
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Fremont, California, 미국, 94538
- Kaiser Permanente-Fremont/Hayward Medical Centers
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Los Angeles, California, 미국, 90015
- AIDS Healthcare Foundation
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Los Angeles, California, 미국, 90028
- Los Angeles Gay and Lesbian Community Service Ctr
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San Francisco, California, 미국, 94110
- Community Consortium / UCSF
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San Francisco, California, 미국, 94110
- Dr. Shawn Hassler
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San Francisco, California, 미국, 94110
- East Bay AIDS Ctr
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San Francisco, California, 미국, 94110
- Lawrence Goldyn, MD
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Colorado
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Denver, Colorado, 미국, 80204-4507
- Drs. Lichtenstein & Greenberg
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Denver, Colorado, 미국, 80204-4507
- Western Infectious Disease Consultants
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Denver, Colorado, 미국, 802044507
- Denver CPCRA / Denver Public Hlth
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Denver, Colorado, 미국, 80204
- McDowell Healthcare Center
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Connecticut
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New Haven, Connecticut, 미국, 065102483
- Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
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New Haven, Connecticut, 미국, 06510
- Veterans Administration Medical Center
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Delaware
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Wilmington, Delaware, 미국, 19801
- Christiana Care Health Services HIV Program George
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District of Columbia
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Washington, District of Columbia, 미국, 204220001
- Timothy A Price
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Washington, District of Columbia, 미국, 20422
- George Washington Univ
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Washington, District of Columbia, 미국, 20422
- Washington Reg AIDS Prog / Dept of Infect Dis
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Florida
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Miami, Florida, 미국, 33125
- Miami Veterans Affairs Med Ctr
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Pensacola, Florida, 미국, 32504
- Center for Prevention and Treatment of Infections
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Vero Beach, Florida, 미국, 32960
- Treasure Coast Infectious Disease Consultants
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Georgia
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Atlanta, Georgia, 미국, 30308
- Absolute Care Clinic
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Atlanta, Georgia, 미국, 30308
- AID Atlanta/Morehouse Med School Ryan White Cl
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Atlanta, Georgia, 미국, 30308
- AIDS Research Consortium of Atlanta (ARCA) Central
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Atlanta, Georgia, 미국, 30308
- Cobb-Douglas County Infectious Disease Clinic
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Atlanta, Georgia, 미국, 30308
- Dekalb County Health Dept Infectious Disease
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Atlanta, Georgia, 미국, 30308
- Dr. Dennis Melton (private practice)
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Atlanta, Georgia, 미국, 30308
- Dr. Melanie Thompson and Dr. Annette Bernard (private practice)
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Atlanta, Georgia, 미국, 30308
- Dr. Richard Hudson (private practice)
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Idaho
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Boise, Idaho, 미국, 83704
- HIV Services Clinic/Family Practice Medical Center
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Illinois
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Chicago, Illinois, 미국, 606576156
- Cook County Hosp
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Chicago, Illinois, 미국, 606576156
- Klein and Slotten Associates / AIDS Research Alliance
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Chicago, Illinois, 미국, 606576156
- Lakeshore Infectious Disease Associates
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Chicago, Illinois, 미국, 606576156
- University of Illinois at Chicago
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Chicago, Illinois, 미국, 60657
- AIDS Research Alliance - Chicago
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Chicago, Illinois, 미국, 60657
- Northside Family Medicine
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Chicago, Illinois, 미국, 60657
- Northwestern Memorial Physicians
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Chicago, Illinois, 미국, 60657
- University of Chicago
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Springfield, Illinois, 미국, 62702
- Southern Illinois University (SIU) School of Medicine
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Kansas
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Wichita, Kansas, 미국, 37214-3199
- KU Medical School-Wichita, Midtown Clinic
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Wichita, Kansas, 미국, 37214-3199
- KU Medical School-Wichita, MPA
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Louisiana
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New Orleans, Louisiana, 미국, 70112-2699
- University of Mississippi Medical Center
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New Orleans, Louisiana, 미국, 701122699
- Our Lady of the Lake Regional Med Ctr
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New Orleans, Louisiana, 미국, 70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Community Research Initiatives of New England
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Boston, Massachusetts, 미국, 02215
- Community Research Initiatives/ProACT
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Springfield, Massachusetts, 미국, 01107
- Community Research Initiative/ProACT
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Michigan
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Ann Arbor, Michigan, 미국, 48100-0378
- University of Michigan Health System
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Detroit, Michigan, 미국, 48202
- Henry Ford Hosp
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Detroit, Michigan, 미국, 48201
- Detroit Community Health Connection
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Detroit, Michigan, 미국, 48201
- Detroit Receiving
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Detroit, Michigan, 미국, 48201
- Wayne State Univ / Medical College of Ohio at Toledo
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Detroit, Michigan, 미국, 48202
- Mt. Clemens General Hospital
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Detroit, Michigan, 미국, 48202
- Providence Hosp- Newland Med Assoc. Inc.
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Grand Rapids, Michigan, 미국, 49503
- McAuley Health Center
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Lansing, Michigan, 미국, 48910
- Michigan State University Infectious Diseases Clinic
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Royal Oak, Michigan, 미국, 48073
- William Beaumont Hospital/CORNET
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic/CORNET
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New Jersey
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Camden, New Jersey, 미국, 08103
- Cooper Hospital Early Intervention Program
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Neptune, New Jersey, 미국, 07753
- Jersey Shore Med Ctr
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Newark, New Jersey, 미국, 07103
- Jeffrey Bomser Clinic / NJCR
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Newark, New Jersey, 미국, 071032842
- Raritan Bay Med Ctr
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Newark, New Jersey, 미국, 071032842
- Saint Michael's Med Ctr
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Newark, New Jersey, 미국, 07103
- New Jersey Community Research Initiative
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Newark, New Jersey, 미국, 07103
- NJCRI
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Somers Poinnt, New Jersey, 미국, 08244
- South Jersey Infectious Disease
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New York
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Bronx, New York, 미국, 10453
- Bronx-Lebanon Hosp Ctr
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Bronx, New York, 미국, 10468
- Bronx Veterans Affairs Medical Center
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Brooklyn, New York, 미국, 11023
- SUNY Downstate Med Ctr
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New York, New York, 미국, 10037
- Grant Houses Health Ctr
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New York, New York, 미국, 10037
- HHC MMC Unit #1
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New York, New York, 미국, 10037
- HHC Outpatient Clinics
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New York, New York, 미국, 10037
- Jacobi Medical Center
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New York, New York, 미국, 10037
- Lenox Avenue Health Ctr
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New York, New York, 미국, 10037
- Lincoln Medical & Mental Health Center
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New York, New York, 미국, 10037
- Polo Grounds Health Care Ctr
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New York, New York, 미국, 10037
- Syndenham Neighborhood Family Care Ctr
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New York, New York, 미국, 10039
- Metropolitan Hospital Center
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157-1042
- Wake Forest Univ Health Sciences
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Univ of Oklahoma Health Sciences
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Oregon
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Portland, Oregon, 미국, 97210
- The Research and Education Group
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Portland, Oregon, 미국, 97209-2534
- Legacy Clinic NE
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Portland, Oregon, 미국, 97209-2534
- Salem Hospital
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Portland, Oregon, 미국, 972105311
- The Research & Education Group / Multomah Cnty Hlth Dept
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Portland, Oregon, 미국, 972105311
- The Research & Education Group / The R & E Grp Office
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Portland, Oregon, 미국, 972105311
- The Research & Education Grp / Oregon Hlth Sci Univ
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Portland, Oregon, 미국, 972105311
- The Rsch & Ed Grp / Legacy Cln at Good Samaritan
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Portland, Oregon, 미국, 972105311
- The Rsch & Ed Grp / Providence Portland Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Philadelphia FIGHT
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Philadelphia, Pennsylvania, 미국, 19107
- Penn Community Infectious Diseases
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Philadelphia, Pennsylvania, 미국, 19140
- Einstein Medical Center
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Philadelphia, Pennsylvania, 미국, 19140
- Temple Univ School of Medicine
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Texas
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Houston, Texas, 미국, 77030
- Houston Veterans Administration Med Ctr
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Houston, Texas, 미국, 77006
- Montrose Clinic
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Houston, Texas, 미국, 77030
- Univ TX Health Science Ctr
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Houston, Texas, 미국, 77030
- University Clinical Research Center
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San Antonio, Texas, 미국, 78229
- South Texas Veterans Health Care System
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Virginia
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Lynchburg, Virginia, 미국, 24501
- Infectious Disease Associates of Virginia
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Richmond, Virginia, 미국, 232980049
- Cross Over Clinic / Div of Infectious Diseases
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Richmond, Virginia, 미국, 232980049
- McGuire VA / Division of Infectious Diseases
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Richmond, Virginia, 미국, 23298
- MCV ID Clinic
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Richmond, Virginia, 미국, 23298
- MediCorp, Infectious Disease Associates
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Richmond, Virginia, 미국, 23298
- Petersburg Health Care Alliance
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Richmond, Virginia, 미국, 23298
- South Richmond Health Ctr
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Richmond, Virginia, 미국, 23298
- Vernon J. Harris East End Community Health Care Ct
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program
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Antwerp, 벨기에, 2000
- Institute of Tropical Medicine
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Liege, 벨기에, 4000
- Centre Hospitalier Universitaire Sart-Tilman
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Boqueirao-Santos, 브라질, 11045-904
- Cassiano Antonio de Moraes University Hospital
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Boqueirao-Santos, 브라질, 11045-904
- Centro de Pesquisa Clinical do Hospital Guilherme
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Porto Alegre-RS Cep, 브라질, 90035
- Hospital de Clinicas de Porto Alegre
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Rio de Janeiro, 브라질, 20221-903
- Hospital dos Servidores do Estado
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Salvador-BA, 브라질, 110-160
- Hospital Universitario Professor Edgard Santos
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San Paulo, 브라질, 04121-000
- Centro de Referência e Treinamento DST/AIDS
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San Paulo, 브라질, 13083-970
- Unidade de Pesquisa Clínica
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Sao Paulo, 브라질, 01246-900
- Ambulatorio de Imunodeficiencias Secundarias/Der30
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Sao Paulo, 브라질, 04040-002
- Universidade Federal De Sao Paulo-Hospital Sao Paulo
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RJ
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Rio de Janeiro, RJ, 브라질, 20210.030
- Hospital Escola Sao Francisco de Asis
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RS
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Porto Alegre, RS, 브라질, 91350-200
- Hospital Nossa Senhora da Conceicao
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S.p. Cep
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Sao Paulo, S.p. Cep, 브라질, 01246
- Instituto de Infectologia Emilio Ribas
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Basel Ch, 스위스, 4031
- University Hospital Basel
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Bern, 스위스, 3010
- Poliklinik fur Infektiologie
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La Chaux-de-Fonds, 스위스, 2300
- Hopital de la Ville
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Lausanne, 스위스, 1011
- Centre Hospitalier Universitaire Vaudois (CHUV)
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Lugano, 스위스, 6903
- Ospedale Regionale di Lugano
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Barcelona, 스페인, E08025
- Hospital de la Santa Creu i Sant Pau
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Madrid, 스페인, E-28006
- Hospital Universitario de La Princesa
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Madrid, 스페인, E-28805
- Hospital Universitario Príncipe de Asturias
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Sevilla, 스페인, 41013
- Hospital U. Virgen del Rocio
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Terrassa, 스페인, 08221
- Hospital Mutua De Terrassa
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Valencia, 스페인, 46014
- Consorcio Hospital General Universitario de Valencia
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-
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-
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Buenos Aires, 아르헨티나
- Hospital Italiano de Buenos Aires
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Buenos Aires, 아르헨티나
- HOSPITAL DE CLINICAS JOSE DE SAN MARTIN
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Buenos Aires, 아르헨티나
- Hospital de Infecciosas F.J. Muniz
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Buenos Aires, 아르헨티나
- Hospital Gn'l de Agudos JM Ramos Mejia
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Buenos Aires, 아르헨티나
- Hospital Gn'l de Agudos T. Alvarez
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Cordoba, 아르헨티나
- Hospital Rawson
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La Plata, 아르헨티나
- Hospital Interzonall de San Juan de Dios
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Mendoza, 아르헨티나
- Hospital Central
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Rosario, 아르헨티나
- CAICI
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-
-
-
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Dublin 8, 아일랜드
- St. James Hospital
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-
-
-
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Tallinn, 에스토니아, 10617
- West-Tallinn Central Hospital
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-
-
-
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Belfast, 영국, BT12 6BA
- Royal Victoria Hospital
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Birmingham, 영국, B9 5SS
- Hawthorn House, Birmingham Heartlands NHS Trust
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Bristol, 영국, BS10 5NB
- Southmead Hospital
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Carshalton, 영국, SM5, 1AA
- St. Helier Hospital
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Carshalton, Surrey, 영국, SM5, 1AA
- St. Helier Hospital
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Essex, 영국, CO3 3NB
- Essex County Hospital
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Halifax, 영국
- Victoria General Hospital, Q.E. II Health Sciences
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London, 영국, SW10 9NH
- Chelsea And Westminster Hospital
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London, 영국, NW3 2QG
- Royal Free Hospital
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London, 영국, SE1 7EH
- St. Thomas' Hospital
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London, 영국, E9 6SR
- Homerton University Hospital NHS Foundation Trust
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London, 영국, EC1A 7BE
- Barts and The London, NHS Trust
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London, 영국, NW10 7NS
- Central Middlesex Hospital
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London, 영국, SE5 9RS
- T1 Coleridge Unit, North Middlesex Hospital
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London, 영국, SE5 9RS
- The Caldecot Centre, Kings College Hospital NHS Tr
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London, 영국, SW17 ORE
- St. George's Hospital
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London, 영국, W1 2NY
- St. Mary's Hospital
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London, 영국, WC1E 6AU
- The Mortimer Market Center
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Middlesbrough, 영국, TS4 3BW
- The James Cook University Hospital
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Middlesex, 영국, UB1 3HW
- Pasteur Suite, Ealing Hospital
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Newcastle, 영국, NE4 6BE
- Newcastle General Hospital
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Sheffield, 영국, S10 2JF
- Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital
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Watford Wd, 영국, 18 0HB
- Watford Sexual Health Center;Watford General Hosp
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England
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Oxford, England, 영국, OX3 9DU
- John Radcliffe Hospital
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-
-
-
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Vienna, 오스트리아, A-1090
- University of Vienna Medical School, AKH
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-
-
-
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Tel Aviv, 이스라엘, 64239
- Ramathibodi Hospital
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-
-
-
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Antella-Firenze, 이탈리아, 50011
- U.O. Malattie Infettive, H.S.Maria Annunziata
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Asti, 이탈리아, 14100
- SOCDU Malattie Infettive Ospedale Civile Asti
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Brescia, 이탈리아, I-25125
- Instituto de Malattie Infettive e Tropicali
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Busto Arsizio (va), 이탈리아, 21052
- Malattie Infettive Busto
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Modena, 이탈리아, 41100
- Università degli Studi di Modena e Reggio Emilia
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Pavia, 이탈리아, 27100
- Clinica Malattie Infettive
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Rome, 이탈리아, 00149
- I.R.C.C.S."L.Spallanzani"
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Torino, 이탈리아, 10149
- University of Turin
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Torrette Di Ancona, 이탈리아, 71-60020
- Servizio Regionale di Immunologia Clinica e Tipizz
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Venice, 이탈리아
- S.S. Giovanni e Paolo Hospital
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Tokyo, 일본, 162-8655
- AIDS Medical Center, International Medical Center
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Tokyo, 일본, 162-8655
- International Medical Center of Japan
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British Columbia
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Vancouver, British Columbia, 캐나다, V6Z 2C7
- Downtown Infectious Disease Clinic
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, NS B3H 1V7
- Queen Elizabeth Ii Health Sciences Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8N 3Z5
- Hamilton Health Science Centre-McMaster
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London, Ontario, 캐나다, N5Y 3H6
- St. Joseph's Health Care Centre of London
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London, Ontario, 캐나다
- St. Josephs Hospital
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Sudbury, Ontario, 캐나다, P3E 5J1
- The HAVEN Program, HRSRH
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Toronto, Ontario, 캐나다, M5G 2N2
- Tronto General Hospital
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Windsor, Ontario, 캐나다, N8W 1E3
- HIV Care Program, Windsor Regional Hospital
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Quebec
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Fleurimont, Quebec, 캐나다, JIH 5N4
- University de Sherbrooke
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Montreal, Quebec, 캐나다, H2L 4P9
- Clinique médicale l'Actuel
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Montreal, Quebec, 캐나다, H2X 2P4
- Montreal Chest Institute/Royal Victoria Hospital
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Sainte-Foy, Quebec, 캐나다, F1V 4G2
- Centre Hospitalier de l'Université Laval (CHUL)
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Ste-Foy, Quebec, 캐나다, G1V 4P9
- Recherche Clinique Centre Medical Halles de Saint-
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Chiang Mai, 태국, 50120
- Sanpatong Hospital
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Nonthaburi 11000, 태국
- Bamrasnaradura Institute
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Lima, 페루, 13
- Hospital Nacional Guillermo Almenara Irigoyen
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Lima, 페루, 11
- Hospital Nacional Edgardo Rebagliati Martins
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Koszarowa Str. 5, 폴란드
- Wroclaw University School of Medicine
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Curitiba, 푸에르토 리코, 80430-040
- Instituto A. Z. de Pesquisa e Ensino
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Annecy, 프랑스, 74011
- CHU de la Region Annecienne
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Bordeaux, 프랑스, 33076
- Hopital Pellegrin
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Chu-grenoble, 프랑스
- Centre Hospitalier Universitaire
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Colombes, 프랑스
- Hôpital Louis Mourier
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Marseille, 프랑스, 13009
- Hôpital Sainte-Marguerite
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Paris, 프랑스, 75651
- Hôpital Pitié Salpêtrière
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Paris, 프랑스, 75010
- Hopital Saint-Louis
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Burwood Nsw, 호주, 2134
- Burwood Street General Pratice
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Perth, 호주
- Royal Perth Hosp
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Prahan, 호주
- Alfred Hosp
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Prahan, 호주
- Royal Prince Alfred Hospital
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Sydney, 호주
- National Centre in HIV Epidemiology and Clinical Research
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South Australia
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Adelaide, South Australia, 호주
- Royal Adelaide Hospital
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Victoria
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South Yarra, Victoria, 호주
- Prahran Market Clinic
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South Yarra, Victoria, 호주
- The Centre Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
참고: 이 평가판 등록은 2006년 1월 11일에 중단되었습니다.
포함 기준:
- HIV 감염
- 연구 시작 45일 이내에 CD4 세포 수가 350 세포/mm3를 초과함
- 항레트로바이러스 요법을 시작, 변경 또는 중단할 의향이 있는 경우
- 허용되는 피임 방법
- 학업 시작 당시의 건강
- 최소 6개월 동안 연구 가능
- 임상의의 의견으로는 프로토콜을 준수할 수 있음
제외 기준:
- 현재 MDR-HIV, NvR 연구 또는 이 연구의 치료 그룹 중 하나와 일치하지 않는 다른 연구에 참여하고 있습니다. CPCRA FIRST 참가자는 2005년 8월 8일 이후에 SMART 검사를 받을 수 있으며 2005년 9월 19일 또는 그 이후에 SMART로 무작위 배정될 수 있습니다.
- 임신 또는 모유 수유
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 시간 관점: 유망한
공동 작업자 및 조사자
수사관
- 연구 의자: Wafaa El-Sadr, MD, MPH, Harlem AIDS Treatment Group, Harlem Hospital Center
- 연구 의자: James Neaton, PhD, CPCRA Statistcal and Data Management Center / CCBR
간행물 및 유용한 링크
일반 간행물
- Lederman MM, Valdez H. Immune restoration with antiretroviral therapies: implications for clinical management. JAMA. 2000 Jul 12;284(2):223-8. doi: 10.1001/jama.284.2.223.
- Carpenter CC, Cooper DA, Fischl MA, Gatell JM, Gazzard BG, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Saag MS, Schechter M, Schooley RT, Thompson MA, Vella S, Yeni PG, Volberding PA. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JAMA. 2000 Jan 19;283(3):381-90. doi: 10.1001/jama.283.3.381.
- Mocroft A, Katlama C, Johnson AM, Pradier C, Antunes F, Mulcahy F, Chiesi A, Phillips AN, Kirk O, Lundgren JD. AIDS across Europe, 1994-98: the EuroSIDA study. Lancet. 2000 Jul 22;356(9226):291-6. doi: 10.1016/s0140-6736(00)02504-6.
- Tebas P, Henry K, Mondy K, Deeks S, Valdez H, Cohen C, Powderly WG. Effect of prolonged discontinuation of successful antiretroviral therapy on CD4+ T cell decline in human immunodeficiency virus-infected patients: implications for intermittent therapeutic strategies. J Infect Dis. 2002 Sep 15;186(6):851-4. doi: 10.1086/342603. Epub 2002 Aug 28. Erratum In: J Infect Dis 2002 Oct 15;186(8):1198.
- Yerly S, Kaiser L, Perneger TV, Cone RW, Opravil M, Chave JP, Furrer H, Hirschel B, Perrin L. Time of initiation of antiretroviral therapy: impact on HIV-1 viraemia. The Swiss HIV Cohort Study. AIDS. 2000 Feb 18;14(3):243-9. doi: 10.1097/00002030-200002180-00006.
- Borges AH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.
- Castillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Collins S, Mannheimer S, Pett S, Touzeau-Romer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT SMART Study Group. Association of Suboptimal Antiretroviral Therapy Adherence With Inflammation in Virologically Suppressed Individuals Enrolled in the SMART Study. Open Forum Infect Dis. 2017 Dec 22;5(1):ofx275. doi: 10.1093/ofid/ofx275. eCollection 2018 Jan.
- Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.
- Nordell AD, McKenna M, Borges AH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.
- Lucas GM, Cozzi-Lepri A, Wyatt CM, Post FA, Bormann AM, Crum-Cianflone NF, Ross MJ; INSIGHT SMART Study Group. Glomerular filtration rate estimated using creatinine, cystatin C or both markers and the risk of clinical events in HIV-infected individuals. HIV Med. 2014 Feb;15(2):116-23. doi: 10.1111/hiv.12087. Epub 2013 Sep 11.
- Baker JV, Brummel-Ziedins K, Neuhaus J, Duprez D, Cummins N, Dalmau D, DeHovitz J, Lehmann C, Sullivan A, Woolley I, Kuller L, Neaton JD, Tracy RP; INSIGHT SMART Study Team. HIV replication alters the composition of extrinsic pathway coagulation factors and increases thrombin generation. J Am Heart Assoc. 2013 Jul 29;2(4):e000264. doi: 10.1161/JAHA.113.000264.
- Hoy J, Grund B, Roediger M, Ensrud KE, Brar I, Colebunders R, Castro ND, Johnson M, Sharma A, Carr A; INSIGHT SMART Body Composition Substudy Group. Interruption or deferral of antiretroviral therapy reduces markers of bone turnover compared with continuous therapy: The SMART body composition substudy. J Bone Miner Res. 2013 Jun;28(6):1264-74. doi: 10.1002/jbmr.1861.
- Zetterberg E, Neuhaus J, Baker JV, Somboonwit C, Llibre JM, Palfreeman A, Chini M, Lundgren JD; INSIGHT SMART Study Group. Platelet count kinetics following interruption of antiretroviral treatment. AIDS. 2013 Jan 2;27(1):59-68. doi: 10.1097/QAD.0b013e32835a104d.
- Mocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. doi: 10.1371/journal.pone.0040245. Epub 2012 Jul 20.
- Baker JV, Neuhaus J, Duprez D, Cooper DA, Hoy J, Kuller L, Lampe FC, Liappis A, Friis-Moller N, Otvos J, Paton NI, Tracy R, Neaton JD; INSIGHT SMART Study Group. Inflammation predicts changes in high-density lipoprotein particles and apolipoprotein A1 following initiation of antiretroviral therapy. AIDS. 2011 Nov 13;25(17):2133-42. doi: 10.1097/QAD.0b013e32834be088.
- Mocroft A, Lifson AR, Touloumi G, Neuhaus J, Fox Z, Palfreeman A, Vjecha MJ, Hodder S, De Wit S, Lundgren JD, Phillips AN; INSIGHT SMART Study Group. Haemoglobin and anaemia in the SMART study. Antivir Ther. 2011;16(3):329-37. doi: 10.3851/IMP1746.
- Duprez DA, Neuhaus J, Tracy R, Kuller LH, Deeks SG, Orkin C, Stoehr A, Woolley IJ, Neaton JD; INSIGHT SMART Group. N-terminal-proB-type natriuretic peptide predicts cardiovascular disease events in HIV-infected patients. AIDS. 2011 Mar 13;25(5):651-7. doi: 10.1097/QAD.0b013e32834404a1.
- Lampe FC, Duprez DA, Kuller LH, Tracy R, Otvos J, Stroes E, Cooper DA, Hoy J, Paton NI, Friis-Moller N, Neuhaus J, Liappis AP, Phillips AN; INSIGHT SMART Study Group. Changes in lipids and lipoprotein particle concentrations after interruption of antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Jul;54(3):275-84. doi: 10.1097/qai.0b013e3181d32158.
- Dore GJ, Soriano V, Rockstroh J, Kupfer B, Tedaldi E, Peters L, Neuhaus J, Puoti M, Klein MB, Mocroft A, Clotet B, Lundgren JD; SMART INSIGHT study group. Frequent hepatitis B virus rebound among HIV-hepatitis B virus-coinfected patients following antiretroviral therapy interruption. AIDS. 2010 Mar 27;24(6):857-65. doi: 10.1097/QAD.0b013e328334bddb.
- Rodger AJ, Fox Z, Lundgren JD, Kuller LH, Boesecke C, Gey D, Skoutelis A, Goetz MB, Phillips AN; INSIGHT Strategies for Management of Antiretroviral Therapy (SMART) Study Group. Activation and coagulation biomarkers are independent predictors of the development of opportunistic disease in patients with HIV infection. J Infect Dis. 2009 Sep 15;200(6):973-83. doi: 10.1086/605447.
- Grund B, Peng G, Gibert CL, Hoy JF, Isaksson RL, Shlay JC, Martinez E, Reiss P, Visnegarwala F, Carr AD; INSIGHT SMART Body Composition Substudy Group. Continuous antiretroviral therapy decreases bone mineral density. AIDS. 2009 Jul 31;23(12):1519-29. doi: 10.1097/QAD.0b013e32832c1792.
- Duprez DA, Kuller LH, Tracy R, Otvos J, Cooper DA, Hoy J, Neuhaus J, Paton NI, Friis-Moller N, Lampe F, Liappis AP, Neaton JD; INSIGHT SMART Study Group. Lipoprotein particle subclasses, cardiovascular disease and HIV infection. Atherosclerosis. 2009 Dec;207(2):524-9. doi: 10.1016/j.atherosclerosis.2009.05.001. Epub 2009 May 13.
- Mocroft A, Wyatt C, Szczech L, Neuhaus J, El-Sadr W, Tracy R, Kuller L, Shlipak M, Angus B, Klinker H, Ross M; INSIGHT SMART Study Group. Interruption of antiretroviral therapy is associated with increased plasma cystatin C. AIDS. 2009 Jan 2;23(1):71-82. doi: 10.1097/QAD.0b013e32831cc129.
- Fox Z, Phillips A, Cohen C, Neuhaus J, Baxter J, Emery S, Hirschel B, Hullsiek KH, Stephan C, Lundgren J; SMART Study Group. Viral resuppression and detection of drug resistance following interruption of a suppressive non-nucleoside reverse transcriptase inhibitor-based regimen. AIDS. 2008 Nov 12;22(17):2279-89. doi: 10.1097/QAD.0b013e328311d16f.
- Tedaldi E, Peters L, Neuhaus J, Puoti M, Rockstroh J, Klein MB, Dore GJ, Mocroft A, Soriano V, Clotet B, Lundgren JD; SMART Study Group and International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Opportunistic disease and mortality in patients coinfected with hepatitis B or C virus in the strategic management of antiretroviral therapy (SMART) study. Clin Infect Dis. 2008 Dec 1;47(11):1468-75. doi: 10.1086/593102.
- Kuller LH, Tracy R, Belloso W, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Neuhaus J, Nixon D, Paton NI, Neaton JD; INSIGHT SMART Study Group. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection. PLoS Med. 2008 Oct 21;5(10):e203. doi: 10.1371/journal.pmed.0050203.
- SMART Study Group, El-Sadr WM, Grund B, Neuhaus J, Babiker A, Cohen CJ, Darbyshire J, Emery S, Lundgren JD, Phillips A, Neaton JD. Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: a randomized trial. Ann Intern Med. 2008 Sep 2;149(5):289-99. doi: 10.7326/0003-4819-149-5-200809020-00003.
- Strategies for Management of Anti-Retroviral Therapy/INSIGHT; DAD Study Groups. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients. AIDS. 2008 Sep 12;22(14):F17-24. doi: 10.1097/QAD.0b013e32830fe35e.
- Gordin FM, Roediger MP, Girard PM, Lundgren JD, Miro JM, Palfreeman A, Rodriguez-Barradas MC, Wolff MJ, Easterbrook PJ, Clezy K, Slater LN. Pneumonia in HIV-infected persons: increased risk with cigarette smoking and treatment interruption. Am J Respir Crit Care Med. 2008 Sep 15;178(6):630-6. doi: 10.1164/rccm.200804-617OC. Epub 2008 Jul 10.
- Phillips AN, Carr A, Neuhaus J, Visnegarwala F, Prineas R, Burman WJ, Williams I, Drummond F, Duprez D, Belloso WH, Goebel FD, Grund B, Hatzakis A, Vera J, Lundgren JD. Interruption of antiretroviral therapy and risk of cardiovascular disease in persons with HIV-1 infection: exploratory analyses from the SMART trial. Antivir Ther. 2008;13(2):177-87. doi: 10.1177/135965350801300215.
- Strategies for Management of Antiretroviral Therapy (SMART) Study Group, Lundgren JD, Babiker A, El-Sadr W, Emery S, Grund B, Neaton JD, Neuhaus J, Phillips AN. Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: role of CD4+ Cell counts and HIV RNA levels during follow-up. J Infect Dis. 2008 Apr 15;197(8):1145-55. doi: 10.1086/529523.
- Strategies for Management of Antiretroviral Therapy (SMART) Study Group, Emery S, Neuhaus JA, Phillips AN, Babiker A, Cohen CJ, Gatell JM, Girard PM, Grund B, Law M, Losso MH, Palfreeman A, Wood R. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis. 2008 Apr 15;197(8):1133-44. doi: 10.1086/586713.
- Carr A, Grund B, Neuhaus J, El-Sadr WM, Grandits G, Gibert C, Prineas RJ; SMART Study Investigators. Asymptomatic myocardial ischaemia in HIV-infected adults. AIDS. 2008 Jan 11;22(2):257-67. doi: 10.1097/QAD.0b013e3282f20a77.
- Burman WJ, Grund B, Roediger MP, Friedland G, Darbyshire J, Wu AW; SMART Study Group. The impact of episodic CD4 cell count-guided antiretroviral therapy on quality of life. J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):185-93. doi: 10.1097/QAI.0b013e31815acaa4.
- Strategies for Management of Antiretroviral Therapy (SMART) Study Group, El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fatkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006 Nov 30;355(22):2283-96. doi: 10.1056/NEJMoa062360.
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 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
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CDC FoundationGilead Sciences알려지지 않은
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University of WashingtonNational Institute of Mental Health (NIMH)모병
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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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Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
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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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Erasmus Medical Center모집하지 않고 적극적으로