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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00120393
First received: July 12, 2005
Last updated: February 3, 2010
Last verified: July 2009

July 12, 2005
February 3, 2010
January 2004
May 2006   (final data collection date for primary outcome 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.
Not Provided
Complete list of historical versions of study NCT00120393 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
    Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
    Other Name: Reyataz
  • 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.
  • Active Comparator: G1
    Intervention: Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
  • Active Comparator: G2
    Intervention: Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
May 2006
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00120393
AI424-100
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP