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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00035932 |
Purpose
The purpose of this study is to learn how well atazanavir works in combination with ritonavir or saquinavir with tenofovir and a nucleoside to reduce the viral load of treatment experienced subjects with HIV. There is a comparison arm with lopinavir/ritonavir and tenofovir and a nucleoside.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir + ritonavir + tenofovir + nucleoside Drug: Atazanavir + saquinavir + tenofovir + nucleoside Drug: Lopinavir/ritonavir + tenofovir + nucleoside |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV |
| Enrollment: | 358 |
| Study Start Date: | November 2001 |
| Estimated Study Completion Date: | December 2008 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Active Comparator
ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
Drug: Atazanavir + ritonavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral
|
|
II: Active Comparator
ATV 300 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
Drug: Atazanavir + saquinavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral
|
|
III: Active Comparator
LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
Drug: Lopinavir/ritonavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Virologic failure to two or more HAART regimens that, in total, have included at least one drug from all approved classes (PI, NNRTI, NRTI):
Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:
Exclusion Criteria:
Any one of the following:
Contacts and Locations
Show 29 Study Locations| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | AI424-045 |
| Study First Received: | May 6, 2002 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00035932 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Infection Reverse Transcriptase Inhibitors Lopinavir Anti-Retroviral Agents Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil 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 HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |