Strategic Timing of Antiretroviral Treatment (START)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council (MRC) Clinical Trials Unit -- London, United Kingdom
The Kirby Institute for Infection and Immunity in Society
The Institute for Clinical Research at the Veterans Affairs Medical Center -- Washington, D.C., USA
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck Sharp & Dohme Corp.
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00867048
First received: March 20, 2009
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

Objectives:

  • To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
  • To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

Condition Intervention Phase
HIV Infection
Drug: All licensed antiretroviral medications
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strategic Timing of AntiRetroviral Treatment

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Components of the composite primary outcome measure [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
  • Specific non-AIDS diagnoses [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
  • Hospitalization, health-care utilization, quality of life [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • HIV drug resistance and transmission risk behavior [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
  • Change in neurocognitive function (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants) [ Time Frame: Blood taken at study entry and stored in a central repository indefinitely ] [ Designated as safety issue: No ]
  • Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites) [ Time Frame: Before randomization into START ] [ Designated as safety issue: No ]
  • Large and small artery elasticity (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Rate of lung function decline (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Changes in bone mineral density (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

Enrollment: 4688
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early ART
Initiate ART immediately following randomization
Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Active Comparator: Deferred ART
Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops
Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Signed informed consent
  • HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed* ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
  • Age greater than or equal to 18 years
  • Karnofsky performance score greater than or equal to 80 (an indication that the participant can perform normal activities)
  • Perceived life expectancy of at least 6 months
  • For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed
  • Two CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60 days before randomization

    • The term licensed refers to an FDA-approved kit or, for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country. Confirmation of the initial test result must use a test method that is different than the one used for the initial assessment.

EXCLUSION CRITERIA:

  • Any previous use of ART or interleukin-2 (IL-2)
  • Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection)
  • Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever
  • Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization
  • Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization
  • Dialysis within 6 months before randomization
  • Diagnosis of decompensated liver disease before randomization
  • Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness
  • Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867048

  Hide Study Locations
Locations
United States, California
UCLA CARE-4-Families (LABAC CRS)
Los Angeles, California, United States, 90095
University of Southern California
Los Angeles, California, United States, 90033
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Naval Medical Center San Diego
San Diego, California, United States, 92134-1201
UCSD Mother-Child-Adolescent Program
San Diego, California, United States, 92103
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington DC VA Medical Center
Washington, District of Columbia, United States, 20422
Georgetown University
Washington, District of Columbia, United States, 20007
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
University of Florida Health Services Center
Jacksonville, Florida, United States, 32209
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32206
University of Miami
Miami, Florida, United States, 33136
Florida Department of Health in Orange County/Hug Me
Orlando, Florida, United States, 32805
Orlando Immunology Center
Orlando, Florida, United States, 32803
Infectious Diseases Associates NW FL, PA
Pensacola, Florida, United States, 32504
USF Health - HIV Clinical Research Unit
Tampa, Florida, United States, 33602
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, United States, 32960
United States, Illinois
Lurie Children's Hospital
Chicago, Illinois, United States, 60611-2605
Mt. Sinai Hospital
Chicago, Illinois, United States, 60608
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02111
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
MMRF, Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
New Jersey Medical School Adult Clinical Research Center
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10452
Montefiore Medical Center
Bronx, New York, United States, 10467
Cornell CRS
New York, New York, United States, 10011
United States, North Carolina
UNC AIDS Clinical Trials Unit
Chapel Hill, North Carolina, United States, 27514
Duke University
Durham, North Carolina, United States, 27710
Regional Center for Infectious Disease
Greensboro, North Carolina, United States, 27401-1209
Wake County Human Services
Raleigh, North Carolina, United States, 27610
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157-1042
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
The Research and Education Group - Portland
Portland, Oregon, United States, 97210
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Adult Special Care Center
Memphis, Tennessee, United States, 38103
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-3678
United States, Texas
UT Southwestern Clinical Research Unit
Dallas, Texas, United States, 75235
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
San Antonio Military Health System
San Antonio, Texas, United States, 78234
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
AIDS Resource Center of Wisconsin
Milwaukee, Wisconsin, United States, 53203
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires, Argentina
Hospital Interzonal General de Agudos Dr. Diego Paroissien
La Matanza, Buenos Aires, Argentina
Instituto CAICI
Rosario, Santa Fe, Argentina
FUNCEI
Buenos Aires, Argentina
Fundacion IDEAA
Buenos Aires, Argentina
Hospital General de Agudos Teodoro Alvarez
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital General de Agudos JM Ramos Mejia
Buenos Aires, Argentina
Hospital Rawson
Cordoba, Argentina
CEIN
Neuquen, Argentina
Australia, New South Wales
Burwood Road General Practice
Burwood, New South Wales, Australia, 2134
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
East Sydney Doctors
Darlinghurst, New South Wales, Australia, 2010
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia, 2010
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Sexual Health and HIV Service - Clinic 2
Brisbane, Queensland, Australia, 4000
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Prahran Market Clinic
Melbourne, Victoria, Australia, 3181
Melbourne Sexual Health Centre
Melbourne, Victoria, Australia, 3053
Centre Clinic
St Kilda, Victoria, Australia, 3182
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Austria
Otto-Wagner-Spital SMZ /Baumgartner Hoehe
Vienna, Austria
University Vienna General Hospital
Vienna, Austria
Belgium
Institute of Tropical Medicine
Antwerp, Belgium
Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
Brussels, Belgium
Universitaire Ziekenhuizen Gent
Ghent, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium
Brazil
SEI - Servicos Especializados em Infectologia
Salvador, BA, Brazil, 40110-010
Center for Infectious Diseases at the UFES
Vitoria, ES, Brazil, 29040-091
Ipec/Fiocruz
Rio de Janeiro, RJ, Brazil, 21040-900
Hospital Escola Sao Francisco de Assis - UFRJ
Rio de Janeiro, RJ, Brazil, 20210-030
Centro de Referencia e Treinamento DST/Aids
Sao Paulo, SP, Brazil, 04121-000
Instituto de Infectologia Emilio Ribas - IIER
Sao Paulo, SP, Brazil, 01246-900
Lim 56/Hcfmusp
Sao Paulo, SP, Brazil, 05403-000
Chile
Fundacion Arriaran
Santiago, Chile
Czech Republic
University Hospital Plzen, CZ
Plzen, Czech Republic
Faculty Hospital Na Bulovce, Prague, Czech Rep.
Prague, Czech Republic
Denmark
Arhus Universitetshospital, Skejby
Aarhus, Denmark
Rigshospitalet, Department of Infectious Diseases, M5112 CRS
Copenhagen, Denmark
Hvidovre University Hospital, Department of Infectious Diseases CRS
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
Estonia
West Tallin Central Hospital Infectious Diseases
Tallinn, Estonia
Finland
Helsinki University Central Hospital, Div. of Infectious Diseases CRS
Helsinki, HUS, Finland
France
Hopital Hotel Dieu
Paris, Cedex 04, France
Hopital Saint-Antoine
Paris, Cedex 12, France
Groupe Hospitalier Pitie-Salpetriere
Paris, Cedex 13, France
CHU Cote de Nacre
Caen, Cedex, France
Hopital Antoine Beclere
Clamart, Cedex, France
Hopital de Bicetre
Le Kremlin-Bicetre, Cedex, France
Hopital Gustave Dron
Tourcoing, Cedex, France
CHU de BESANCON - Hopital Saint Jacques
Besancon, France
Hopital Henri Mondor
Creteil, France
Hopital Saint-Louis
Paris, France
Hopital Europeen Georges Pompidou
Paris, France
Hopital Foch
Suresnes, France
Germany
Gemeinschaftspraxis Jessen-Jessen-Stein
Berlin, Germany
EPIMED-Gesellschaft fuer epidemiologische und klinische Forschung in der MedizinmbH
Berlin, Germany
Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS
Bonn, Germany
Klinik I fur Innere Medizin der Universitat zu Koeln, Studienbuero fuer Infektiologie u. HIV CRS
Cologne, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany
Universitaetsklinikum Erlangen
Erlangen, Germany
Klinik fur Dermatologie, Venerologie, Allergologie
Essen, Germany
Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
Frankfurt, Germany
ICH Study Center
Hamburg, Germany
Ifi - Studien und Projekte GmbH
Hamburg, Germany
University Medical Centre Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Klinikum der Universitaet Muenchen
Munich, Germany
Universitaetsklinikum Regensburg
Regensburg, Germany
University of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektologie CRS
Wuerzburg, Germany
Greece
AHEPA University Hospital
Thessaloniki, Central Macedonia, Greece
Syngros Hospital
Athens, Greece
Korgialenio-Benakio Hellenic Red Cross
Athens, Greece
Hippokration University General Hospital of Athens
Athens, Greece
Attikon University General Hospital
Athens, Greece
Evangelismos General Hospital
Athens, Greece
India
Institute of Infectious Diseases
Pune, Maharashtra, India, 411037
YRGCARE Medical Centre VHS, Chennai CRS
Chennai, Tamil Nadu, India, 600113
Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Israel
Rambam Medical Center
Haifa, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Italy
Ospedale San Raffaele S.r.l.
Milan, MI, Italy
Lazzaro Spallanzani IRCSS
Rome, RM, Italy
Luxembourg
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Federal Territory, Malaysia
Mali
Serefo/Cesac Mali
Bamako, Mali
Mexico
INCMNSZ
Tlalpan, D.f., Mexico
Morocco
University Hospital Centre Ibn Rochd
Casablanca, Morocco, 20360
Nigeria
Institute of Human Virology-Nigeria (IHVN)
Abuja, FCT, Nigeria
Norway
Oslo University Hospital, Ulleval
Oslo, Norway
Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, Peru, 11
Via Libre
Lima, Peru, 01
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Peru, 13
Asociacion Civil Impacta Salud y Educacion
Lima, Peru, 04
IMPACTA San Miguel
Lima, Peru, 32
Poland
Wojewodzki Szpital Specjalistyczny
Bialystok, Poland
Wojewodzki Szpital Zakazny
Warsaw, Poland
EMC Instytut Medyczny SA
Wroclaw, Poland
Portugal
Hospital de Egas Moniz
Lisbon, Portugal
Hospital de Santa Maria
Lisbon, Portugal
Hospital Curry Cabral
Lisbon, Portugal
Hospital Joaquim Urbano
Oporto, Portugal
Puerto Rico
San Juan Hospital
Rio Piedras, Puerto Rico, 00935
Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)
San Juan, Puerto Rico, 00935
University of Puerto Rico Pediatric Research Site
San Juan, Puerto Rico, 00935-6528
South Africa
CHRU
Johannesburg, Gauteng, South Africa
1 Military Hospital
Pretoria, Gauteng, South Africa
University KZN
Durban, KwaZulu-Natal, South Africa
DICTU
Durban, KwaZulu-Natal, South Africa
Desmond Tutu HIV Foundation Clinical Trials Unit
Cape Town, Western Cape, South Africa
Spain
Hospital Universitari Germans Trias I Pujol, HIV Unit and Retrovirology Lab CRS
Badalona, Barcelona, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Principe de Asturias
Alcala de Henares, Madrid, Spain
Complejo Hospitalario Xeral Cies
Vigo, Pontevedra, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clinico de Barcelona CRS
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS
Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Skane University Hospital
Malmo, Sweden
Switzerland
University Hospital Basel
Basel, Switzerland
Bern University Hospital
Bern, Switzerland
Unite VIH/SIDA Geneva
Geneva, Switzerland
University Hospital Zurich
Zurich, Switzerland
Thailand
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Chulalongkorn University Hospital
Bangkok, Thailand, 10330
Ramathibodi Hospital
Bangkok, Thailand, 10400
Sanpatong Hospital
Chiang Mai, Thailand, 50120
Research Institute for Health Sciences (RIHES)
Chiang Mai, Thailand, 50200
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand, 57000
Chonburi Regional Hospital
Chonburi, Thailand, 20000
Khon Kaen University, Srinagarind Hospital
Khon Kaen, Thailand, 40002
Bamrasnaradura Institute
Nonthaburi, Thailand, 11000
Uganda
MRC/UVRI Research Unit on AIDS
Entebbe, Uganda
Joint Clinical Research Center (JCRC)
Kampala, Uganda
United Kingdom
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom, RG1 5LE
The James Cook University Hospital
Middlesbrough, Cleveland, United Kingdom, TS4 3BW
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom, BN2 1ES
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW
Belfast Health and Social Care Trust (RVH)
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2WB
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom, B9 5SS
Coventry and Warwickshire NHS partnership Trust
Coventry, West Midlands, United Kingdom, CV1 4FS
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Gloucestershire Royal Hospital
Gloucester, United Kingdom, GL1 3NN
Guy's and St.Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Barts Health NHS Trust
London, United Kingdom, E1 1BB
University College London Medical School
London, United Kingdom, WC1E 6JB
South London Healthcare NHS Trust
London, United Kingdom, SE18 4QH
St. George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council (MRC) Clinical Trials Unit -- London, United Kingdom
The Kirby Institute for Infection and Immunity in Society
The Institute for Clinical Research at the Veterans Affairs Medical Center -- Washington, D.C., USA
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck Sharp & Dohme Corp.
Tibotec Pharmaceutical Limited
Investigators
Principal Investigator: James D Neaton, PhD University of Minnesota - Clinical and Translational Science Institute
Study Chair: Abdel Babiker, PhD Medical Research Council Clinical Trials Unit, London
Study Chair: Sean Emery, PhD National Centre in HIV Epidemiology & Clinical Research, UNSW, Sydney
Study Chair: Fred Gordin, MD Veterans Affairs Medical Center -- Washington, DC
Study Chair: Jens Lundgren, MD, DMSc Copenhagen HIV Programme
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00867048     History of Changes
Obsolete Identifiers: NCT00821171
Other Study ID Numbers: 0603M83587, U01AI068641, 2008-006439-12
Study First Received: March 20, 2009
Last Updated: January 6, 2014
Health Authority: Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Belgium: Institutional Review Board
Brazil: Ethics Committee
Chile: Instituto de Salud Pública de Chile
Czech Republic: Ethics Committee
Denmark: Ethics Committee
Estonia: Research Ethics Committee
European Union: European Medicines Agency
Finland: Ethics Committee
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Greece: Ethics Committee
India: Indian Council of Medical Research
Ireland: Research Ethics Committee
Israel: Ethics Commission
Italy: National Bioethics Committee
Luxembourg: Comite National d'Ethique de Recherche
Mali: Ministry of Health
Mexico: Ethics Committee
Morocco: Ministry of Public Health
Nigeria: The National Agency for Food and Drug Administration and Control
Peru: Ethics Committee
Poland: Ethics Committee
Portugal: Ethics Committee for Clinical Research
South Africa: National Health Research Ethics Council
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission
Thailand: Ethical Committee
Uganda: National Council for Science and Technology
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
highly active antiretroviral therapy (HAART)
CD4 Count
Early Intervention
HIV
HIV Infection
HIV Infections
treatment naive

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014