N/A
N=15
Metabolic Effects of Switching Kaletra to Boosted Reyataz
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00413153 ↗Enrolled (actual)
15
Serious AEs
13.3%
Results posted
Mar 2010
Primary outcome: Primary: Glucose Trafficking — 26.7; 24.4 umol/kg/min — p=0.035
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- atazanavir/ritonavir (Drug); lopinavir/ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Trafficking |
26.7; 24.4 | 0.035 sig |
| SECONDARY Insulin Sensitivity |
39.0; 49.2 | 0.12 |
| SECONDARY Fasting Glucose |
84; 90 | 0.002 sig |
| SECONDARY Lipid Metabolism - Serum Triglyceride |
147; 209 | 0.02 sig |
| SECONDARY Body Composition - Visceral Adipose Tissue |
91; 167 | 0.047 sig |
| SECONDARY Immune Parameters -- CD4 Count |
432; 688 | 0.72 |
| SECONDARY Liver Enzymes -- Aspartate Aminotransferase (AST) |
39; 42 | 0.22 |
| SECONDARY Liver Enzymes -- Alanine Aminotransferase (ALT) |
61; 65 | 0.004 sig |
| SECONDARY Total Bilirubin |
2.8; 0.6 | 0.0002 sig |
Summary
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.
Eligibility Criteria
Inclusion Criteria
- Previously diagnosed HIV infection
- Age between 18-65 years
- Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
- CD4 count > 400 cell/mm3
- Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin >= 15 mIU/ml), hypercholesteremia (fasting total cholesterol >= 200 mg/dL), hypertriglyceridemia (fasting triglycerides >= 150 mg/dL), or treatment with a lipid lowering medication.
Exclusion Criteria
- Hemoglobin < 11.0 g/dL
- History of Diabetes Mellitus
- Currently on medication for Diabetes
- Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Any contraindication to ATV/r or known allergy to ATV
- Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
- New or serious opportunistic infection in the past 3 months
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00413153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.