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

NCT00120393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2010-02-05

No results posted yet for this study

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).

Conditions

  • HIV Infections

Interventions

DRUG

atazanavir/ritonavir +2 NRTIs (immediate Switch Group)

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

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120393 on ClinicalTrials.gov