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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group); Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00120393

AI424-100

Details and patient eligibility

About

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).

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

G1

Active Comparator group

Treatment:

Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)

G2

Active Comparator group

Treatment:

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