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

Phase 3CompletedNCT00120393

Bristol-Myers Squibb192 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

192

Conditions

HIV Infections

Interventions

atazanavir/ritonavir +2 NRTIs (immediate Switch Group)DRUG

Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.

LPV/r +2 NRTIs (Delayed/optional Switch Group)DRUG

Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Local Institution

Phoenix, Arizona, United States

Local Institution

Bakersfield, California, United States

Local Institution

Los Angeles, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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