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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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Local Institution
Phoenix, Arizona, United States
Local Institution
Bakersfield, California, United States
Local Institution
Los Angeles, California, United States
Local Institution
San Francisco, California, United States
Local Institution
Miami, Florida, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
New York, New York, United States
Local Institution
Cincinnati, Ohio, United States
Local Institution
Portland, Oregon, United States
Local Institution
Philadelphia, Pennsylvania, United States
Start Date
January 1, 2004
Primary Completion Date
May 1, 2006
Completion Date
May 1, 2006
Last Updated
February 5, 2010
192
ESTIMATED participants
atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
DRUG
LPV/r +2 NRTIs (Delayed/optional Switch Group)
DRUG
Lead Sponsor
Bristol-Myers Squibb
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330