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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group); Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)

• Registration Number: NCT00120393
• Lead Sponsor: Bristol-Myers Squibb

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-07-12
• Study First Submitted QC: 2005-07-15
• Study First Posted: 2005-07-18
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2009-07
• Disposition First Submitted: 2010-02-03
• Disposition First Submitted QC: 2010-02-03
• Last Update Submitted: 2010-02-03
• Disposition First Posted: 2010-02-05
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
G1	atazanavir/ritonavir +2 NRTIs (immediate Switch Group)	-
G2	LPV/r +2 NRTIs (Delayed/optional Switch Group)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 frequency and severity of all clinical and laboratory AEs and discontinue for AEs.
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.

Trial Locations

Locations (1)

Local Institution; 🇨🇦 Montreal, Quebec, Canada