Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
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ClinicalTrials.gov Identifier: NCT00120393 |
Recruitment Status
:
Completed
First Posted
: July 18, 2005
Last Update Posted
: February 5, 2010
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Estimated Enrollment : | 192 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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. |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | May 2006 |

Arm | Intervention/treatment |
---|---|
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.
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- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120393
United States, Arizona | |
Local Institution | |
Phoenix, Arizona, United States | |
United States, California | |
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Bakersfield, California, United States | |
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Los Angeles, California, United States | |
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San Francisco, California, United States | |
United States, Florida | |
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Miami, Florida, United States | |
United States, Massachusetts | |
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Boston, Massachusetts, United States | |
United States, New York | |
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New York, New York, United States | |
United States, Ohio | |
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Cincinnati, Ohio, United States | |
United States, Oregon | |
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Portland, Oregon, United States | |
United States, Pennsylvania | |
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Philadelphia, Pennsylvania, United States | |
United States, South Carolina | |
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Columbia, South Carolina, United States | |
United States, Texas | |
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Dallas, Texas, United States | |
Canada, Ontario | |
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Hamilton, Ontario, Canada | |
Canada, Quebec | |
Local Institution | |
Montreal, Quebec, Canada |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Responsible Party: | Study Director, Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00120393 History of Changes |
Other Study ID Numbers: |
AI424-100 |
First Posted: | July 18, 2005 Key Record Dates |
Last Update Posted: | February 5, 2010 |
Last Verified: | July 2009 |
Keywords provided by Bristol-Myers Squibb:
Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |