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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00224445 |
Purpose
To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir boosted with ritonavir in treatment naive patients.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Truvada Drug: atazanavir Drug: ritonavir |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Boosted Atazanavir and Truvada Given Once-Daily (BATON Study): A Phase 4 Study of Safety, Efficacy & Adherence in HIV Infected, Antiretroviral Naïve Subjects Treated With a Simple Once-Daily Regimen |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2007 |
To determine the safety and efficacy (viral load suppression and CD4 changes) of a simple, once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with the protease inhibitor atazanavir (ATV) boosted with ritonavir (ATV/r).
To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir.
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
To evaluate steady-state plasma PK of Truvada and atazanavir in study subjects receiving Truvada and boosted atazanavir.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period):
Drugs that are contraindicated with atazanavir and/or ritonavir including:
Contacts and Locations
More Information
| Responsible Party: | John Flaherty, Director, Medical Affairs, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00224445 History of Changes |
| Other Study ID Numbers: | GS-US-164-0115 |
| Study First Received: | September 20, 2005 |
| Last Updated: | April 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment Naive HIV-1 |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Atazanavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |