Clinical trial NCT00120393: Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-07-18
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
measure: Mean change in cholesterol measures at Weeks 12, 24 and 48.
measure: Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
measure: The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
measure: The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
measure: The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
measure: The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Bakersfield
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: New York
country: United States
facility: Local Institution
state: New York
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: