|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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: | Gilead Sciences ( John Flaherty, Director, Medical Affairs ) |
| Study ID Numbers: | GS-US-164-0115 |
| Study First Received: | September 20, 2005 |
| Last Updated: | April 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00224445 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment Naive HIV-1 |
|
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Atazanavir Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |