Metabolic Effects of Switching Kaletra to Boosted Reyataz

NCT00413153 | Completed Results

• 1 other identifier: 2005-P-002239
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.

Conditions

HIV Infections

Keywords

HIV; Kaletra; Reyataz; Insulin sensitivity; Lipids; Body Composition; Receiving Kaletra; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Glucose Trafficking

  6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG \[labeled glucose\] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.

  6 months

Secondary Outcomes (8)

• Insulin Sensitivity

  6 months

• Fasting Glucose

  6 months

• Lipid Metabolism - Serum Triglyceride

  6 months

• Body Composition - Visceral Adipose Tissue

  6 months

• Immune Parameters -- CD4 Count

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Boosted Reyataz (300mg atazanavir + 100mg ritonavir)

Drug: atazanavir/ritonavir

2

ACTIVE COMPARATOR

Kaletra (pre-study dose)

Drug: lopinavir/ritonavir

Interventions

atazanavir/ritonavir DRUG

atazanavir 300mg + ritonavir 100mg once daily

Also known as: Boosted Reyataz

1

lopinavir/ritonavir DRUG

patient remains on their pre-study dose of lopinavir/ritonavir

Also known as: Kaletra

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Stanley TL, Joy T, Hadigan CM, Liebau JG, Makimura H, Chen CY, Thomas BJ, Weise SB, Robbins GK, Grinspoon SK. Effects of switching from lopinavir/ritonavir to atazanavir/ritonavir on muscle glucose uptake and visceral fat in HIV-infected patients. AIDS. 2009 Jul 17;23(11):1349-57. doi: 10.1097/QAD.0b013e32832ba904.

  PMID: 19474651 DERIVED

MeSH Terms

Conditions

HIV Infections; Insulin Resistance

Interventions

atazanavir, ritonavir drug combination; Lopinavir; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Steven K. Grinspoon, MD
• Organization: Massachusetts General Hospital

sgrinspoon@partners.org

617-724-9109

Study Officials

• Steven K Grinspoon, MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 9, 2010
• Results First Posted: March 3, 2010

Record last verified: 2010-03

Locations

US (1)