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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Adult AIDS Clinical Trials Group |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00090779 |
Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
Condition | Intervention |
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HIV Infections |
Drug: Emtricitabine/ tenofovir disoproxil fumarate Drug: Lopinavir/Ritonavir |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | The SETPOINT Study - A Randomized Study of the Effect of Immediate Treatment With Potent Antiretroviral Therapy Versus Observation With Treatment as Indicated in Newly Infected HIV-1 Infected Subjects: Does Early Therapy After the Virologic Setpoint? |
Estimated Enrollment: | 150 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Group 1 will receive emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
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Drug: Emtricitabine/ tenofovir disoproxil fumarate
once daily
Drug: Lopinavir/Ritonavir
twice daily
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2: No Intervention
No Treatment
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Combination antiretroviral therapy has resulted in significantly decreased morbidity and mortality, incidence of opportunistic infections, and hospitalizations in HIV infected people. However, because of long-term toxicities associated with long-term use of antiretrovirals and the persistence of virus in latent reservoirs, it is unclear when it is best to initiate therapy in recently infected individuals. This study will compare the virologic outcomes of adults recently infected with HIV who receive emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), coformulated as Truvada, and lopinavir/ritonavir (LPV/RTV), coformulated as Kaletra, with those who receive no treatment.
This study will last 96 weeks. Participants will be randomly assigned to one of two groups. For the first 36 weeks of the study, Group 1 will receive FTC/TDF once daily and LPV/RTV twice daily. Some Group 1 participants will receive a different ART regimen as determined by the participant and study staff, if appropriate. Group 2 will receive no treatment for the duration of the study. At Week 37, participants from both Group 1 and 2 will be offered treatment continuation or initiation until Week 96 if they have a high viral load, low CD4 count, or are experiencing HIV-related symptoms. Study visits will occur at screening, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 37, 38, 40, and every 4 weeks thereafter. Clinical assessment and blood collection will occur at all visits. Urine tests will occur at selected visits. Participants will be asked to complete an adherence questionnaire at Weeks 12, 24, and 36.
Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Step 1:
Exclusion Criteria for Step 1:
Study Chair: | Christine Hogan, MD | Division of Infectious Diseases, Columbia University College of Physicians and Surgeons |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5217, AIEDRP AIN503, ACTG A5217 |
Study First Received: | September 3, 2004 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00090779 |
Health Authority: | United States: Federal Government |
Acute Infection Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Emtricitabine Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |