Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120393
• Other study ID #: AI424-100
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2005
• Last updated: February 3, 2010
• Start date: January 2004
• Est. completion date: May 2006

Study information

• Verified date: July 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
• 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.

Locations

Country	Name	City	State
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Montreal	Quebec
United States	Local Institution	Bakersfield	California
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Cincinnati	Ohio
United States	Local Institution	Columbia	South Carolina
United States	Local Institution	Dallas	Texas
United States	Local Institution	Los Angeles	California
United States	Local Institution	Miami	Florida
United States	Local Institution	New York	New York
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Portland	Oregon
United States	Local Institution	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
Secondary	Mean change in cholesterol measures at Weeks 12, 24 and 48.
Secondary	Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
Secondary	The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
Secondary	The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
Secondary	The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
Secondary	The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm