Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00120393
First received: July 12, 2005
Last updated: February 3, 2010
Last verified: July 2009
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Purpose
Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group) Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen. |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.
Secondary Outcome Measures:
- Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
- Mean change in cholesterol measures at Weeks 12, 24 and 48.
- Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
- The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
- The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
- The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
- The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.
| Estimated Enrollment: | 192 |
| Study Start Date: | January 2004 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: G1 |
Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
Other Name: Reyataz
|
| Active Comparator: G2 |
Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)
Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV positive
- LPV/RTV-based HAART for at least 6 months
- HIV-1 RNA less than 50c/mL (confirmed)
- Non-HDL higher than 160 mg/dL
- CD4 of at least 50 cells/mL
Exclusion Criteria:
- Use of lipid-lowering agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120393
Locations
| United States, Arizona | |
| Local Institution | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Local Institution | |
| Bakersfield, California, United States | |
| Local Institution | |
| Los Angeles, California, United States | |
| Local Institution | |
| San Francisco, California, United States | |
| United States, Florida | |
| Local Institution | |
| Miami, Florida, United States | |
| United States, Massachusetts | |
| Local Institution | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| Local Institution | |
| New York, New York, United States | |
| United States, Ohio | |
| Local Institution | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Local Institution | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Local Institution | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| Local Institution | |
| Columbia, South Carolina, United States | |
| United States, Texas | |
| Local Institution | |
| Dallas, Texas, United States | |
| Canada, Ontario | |
| Local Institution | |
| Hamilton, Ontario, Canada | |
| Canada, Quebec | |
| Local Institution | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00120393 History of Changes |
| Other Study ID Numbers: | AI424-100 |
| Study First Received: | July 12, 2005 |
| Last Updated: | February 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Treatment Experienced |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on October 16, 2012
