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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
* Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G1<br> | Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)<br>* Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.<br>* Other names: Reyataz;|
| Active Comparator: G2<br> | Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)<br>* Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced