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| Sponsored by: |
Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00028067 |
Purpose
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir Drug: Nelfinavir mesylate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Active Control, Safety/Efficacy Study |
| Official Title: | A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor |
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2001 |
In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients may not be eligible for this study if they:
Contacts and Locations
Show 62 Study Locations| Study Director: | Michael Giordano |
More Information
| Study ID Numbers: | 302F, AI424-037 |
| Study First Received: | December 10, 2001 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00028067 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination HIV Protease Inhibitors RNA, Viral |
Reverse Transcriptase Inhibitors Viral Load BMS 232632 |
|
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Nelfinavir Retroviridae Infections |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors 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 Sexually Transmitted Diseases Lentivirus Infections |