A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy
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ClinicalTrials.gov Identifier: NCT00067782 |
Recruitment Status
:
Completed
First Posted
: August 28, 2003
Last Update Posted
: April 14, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir (immediate switch) Drug: Atazanavir (Week 24 switch) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | December 2002 |
Actual Primary Completion Date : | March 2005 |
Actual Study Completion Date : | March 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: Atazanavir (immediate switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Name: Reyataz
|
Active Comparator: 2 |
Drug: Atazanavir (Week 24 switch)
Capsules, Oral, 400mg, Once daily, 48 weeks.
Other Name: Reyataz
|
- Time to virologic rebound for subjects with HIV RNA < 50 c/mL at baseline; Magnitude/ durability of increases from baseline in absolute CD4 (Time-Averaged Difference) through WK12; Mean % change from baseline in fasting LDL cholesterol at WK12.

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Must be on current HIV treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject's first PI ever received
- Plasma HIV-1 RNA level < 50 c/mL within 3 to 6 months prior to study start
- Fasting LDL cholesterol > 130 mg/dL
Key Exclusion Criteria:
- WOCBP who do not use effective barrier contraception for any reason
- Women who are pregnant or breast feeding
- A life expectancy < 12 months
- Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
- Cushing's Syndrome
- Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome
- Untreated hypothyroidism or hyperthyroidism
- Nephrotic syndrome or significant proteinuria
- Obstructive liver disease
- Active alcohol or substance abuse
- Proven or suspected acute hepatitis in the 30 days prior to study entry
- Intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start
- History of acute or chronic pancreatitis
- Inability to swallow capsules
- Presence of cardiomyopathy
- Known history of prolonged QTc interval
-
Any of the following:
- clinical symptoms potentially related to heart block
- heart rate < 40 bpm
- any of the following EKG abnormalities:
i) pause length > 3 seconds ii) second or third degree AV heart block iii) QTc interval > 450 msec for males iv) QTc interval > 470 msec for females
- Fasting serum triglyceride level > 750 mg/dL
-
Any of the following lab values within 2 weeks of starting study drug:
- serum creatinine greater to or equal to 1.5 times the upper limit of normal
- total serum lipase greater than or equal to 1.4 times the upper limit of normal
- liver transaminases greater than or equal to 3 times the upper limit of normal
- total serum bilirubin greater than or equal to 1.5 times the upper limit of normal
- Hypersensitivity to any component of the formulation of study drug
- Use of any lipid-lowering agent within 4 weeks prior or during study
- Use of a PI-containing ARV regimen prior to entry which is comprised of more than one PI
- Inclusion of an NNRTI in the PI-containing regimen
- Prisoners or subjects involuntary incarcerated for treatment of psychiatric or physical illness

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): NCT00067782
United States, Arizona | |
Local Institution | |
Phoenix, Arizona, United States | |
United States, California | |
Local Institution | |
West Hollywood, California, United States | |
United States, District of Columbia | |
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Washington, District of Columbia, United States | |
United States, Florida | |
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Altamonte Springs, Florida, United States | |
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Ft. Lauderdale, Florida, United States | |
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Miami, Florida, United States | |
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Tampa, Florida, United States | |
United States, Massachusetts | |
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Boston, Massachusetts, United States | |
United States, Minnesota | |
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Minneapolis, Minnesota, United States | |
United States, Missouri | |
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St. Louis, Missouri, United States | |
United States, New Jersey | |
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East Orange, New Jersey, United States | |
United States, New York | |
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New York, New York, United States | |
United States, North Carolina | |
Local Institution | |
Huntersville, North Carolina, United States | |
United States, Ohio | |
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Cleveland, Ohio, United States | |
United States, Oklahoma | |
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Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
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Philadelphia, Pennsylvania, United States | |
United States, South Carolina | |
Local Institution | |
Columbia, South Carolina, United States | |
United States, Texas | |
Local Institution | |
Fort Worth, Texas, United States | |
Local Institution | |
Houston, Texas, United States |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00067782 History of Changes |
Other Study ID Numbers: |
AI424-067 |
First Posted: | August 28, 2003 Key Record Dates |
Last Update Posted: | April 14, 2011 |
Last Verified: | January 2010 |
Keywords provided by Bristol-Myers Squibb:
HIV 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 |
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 |