Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Bristol-Myers Squibb |
---|---|
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00272779 |
The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir plus ritonavir versus a combination drug of lopinavir plus ritonavir. A combination drug containing tenofovir and emtricitabine will also be taken by patients in both arms.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Reyataz + Ritonavir + Truvada Drug: Kaletra + Truvada |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects |
Estimated Enrollment: | 882 |
Study Start Date: | November 2005 |
Study Completion Date: | October 2008 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Active Comparator |
Drug: Reyataz + Ritonavir + Truvada
Capsules, tablets, Oral, ATV (300mg) + RTV (100mg) + TDF-FTC (300/200mg), once daily, up to 96 Weeks
|
II: Active Comparator |
Drug: Kaletra + Truvada
Capsules, tablets, Oral, LPV/RTV (400/100mg) + TDF-FTC (300/200mg), LPV/RTV - twice daily, TDF-FTC - once daily up to 96 Weeks |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI424-138 |
Study First Received: | January 5, 2006 |
Last Updated: | June 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00272779 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Treatment Naive |
Anti-Infective Agents HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases |
Anti-Retroviral Agents Emtricitabine Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Lopinavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases |
Acquired Immunodeficiency Syndrome Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Ritonavir HIV Infections Sexually Transmitted Diseases Lentivirus Infections |