Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
|ClinicalTrials.gov Identifier: NCT00120393|
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : February 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group) Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2004|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
|Active Comparator: G1||
Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
Other Name: Reyataz
|Active Comparator: G2||
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120393
|United States, Arizona|
|Phoenix, Arizona, United States|
|United States, California|
|Bakersfield, California, United States|
|Los Angeles, California, United States|
|San Francisco, California, United States|
|United States, Florida|
|Miami, Florida, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, New York|
|New York, New York, United States|
|United States, Ohio|
|Cincinnati, Ohio, United States|
|United States, Oregon|
|Portland, Oregon, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, South Carolina|
|Columbia, South Carolina, United States|
|United States, Texas|
|Dallas, Texas, United States|
|Hamilton, Ontario, Canada|
|Montreal, Quebec, Canada|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|