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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00821171 |
The purpose of this study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART in HIV-infected adults.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Antiretroviral Treatment |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Strategic Timing of Antiretroviral Treatment (START) |
Estimated Enrollment: | 4000 |
Arms | Assigned Interventions |
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A: Experimental
ART regimen is initiated immediately after randomization
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Drug: Antiretroviral Treatment
Potent combination therapy will be prescribed for all participants by their physicians
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B: Active Comparator
ART regimen is deferred until the CD4 count is measured below 350 cells/mm^3
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Drug: Antiretroviral Treatment
Potent combination therapy will be prescribed for all participants by their physicians
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Data from recent studies indicate that morbidity and mortality risk reduction with earlier use of ART may be greater than previously estimated. This randomized study will determine whether immediate initiation of ART is more effective than deferral of ART until the CD4 count declines below 350 cells/mm^3 in HIV-infected participants who are treatment naive with a CD4 count greater than 500 cells/mm^3.
This study will last approximately 6 years. Participants will be randomly stratified to one of two arms. Participants in Arm A will begin receiving ART immediately after randomization. Participants in Arm B will defer treatment until the CD4 count is measured below 350 cells/mm^3.
All participants taking ART in this study will be prescribed a potent combination therapy chosen by the participant and his or her physician. ART will not be provided by the study.
All participants will have scheduled visits at Months 1 and 4 after randomization and every 4 months thereafter. A targeted physical exam and blood and urine collection will occur at all visits. Behavioral and quality of life assessments will occur annually.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Abdel Babiker, MD | Medical Research Council |
Study Chair: | Sean Emery, PhD | University of New South Wales |
Study Chair: | Fred Gordin, MD | George Washington University |
Study Chair: | Jens Lundgren, MD | University of Copenhagen |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | INSIGHT 001, START |
Study First Received: | January 9, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00821171 |
Health Authority: | United States: Food and Drug Administration |
Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |