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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 | Clinical Trials | Clareo Health

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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

NCT00067782•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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

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
+22 more criteria

Locations (19)

Local Institution

Phoenix, Arizona, United States

Local Institution

West Hollywood, California, United States

Local Institution

Washington D.C., District of Columbia, United States

Local Institution

Altamonte Springs, Florida, United States

Local Institution

Fort Lauderdale, Florida, United States

Local Institution

Miami, Florida, United States

Local Institution

Tampa, Florida, United States

Local Institution

Boston, Massachusetts, United States

Local Institution

Minneapolis, Minnesota, United States

Local Institution

St Louis, Missouri, United States

Key Dates

Start Date

December 1, 2002

Primary Completion Date

March 1, 2005

Completion Date

March 1, 2005

Last Updated

April 14, 2011

Conditions

HIV Infections

Interventions

Atazanavir (immediate switch)

DRUG

Atazanavir (Week 24 switch)

DRUG

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HIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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