Metabolic Effects of Switching Kaletra to Boosted Reyataz - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Bristol-Myers Squibb
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00413153

Purpose

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

Condition	Intervention
HIV Infections	Drug: atazanavir/ritonavir Drug: lopinavir/ritonavir

MedlinePlus related topics: AIDS

Drug Information available for: Insulin Ritonavir Lopinavir Atazanavir sulfate BMS 232632 Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Metabolic Effects of Switching Kaletra to Boosted Reyataz

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Glucose trafficking [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Lipid metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Hepatic glucose production [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Body Composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Immune parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Liver enzymes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Active Comparator Boosted Reyataz (300mg atazanavir + 100mg ritonavir)	Drug: atazanavir/ritonavir atazanavir 300mg + ritonavir 100mg once daily
2: Active Comparator Kaletra (pre-study dose)	Drug: lopinavir/ritonavir patient remains on their pre-study dose of lopinavir/ritonavir

Detailed Description:

The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (Lop/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching PI to ATV/r from LOP/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LOP/r. We will complete a prospective randomized trial of HIV infected patients who have been on a stable ARV regimen containing LOP/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LOP/r for 6 months. Each subject will complete PET 18FDG imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously diagnosed HIV infection
Age between 18-65 years
Stable antiviral regimen containing at least 2 NRTI's and LOP/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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413153

Contacts

Contact: Steven K Grinspoon, MD

617 724-9109

Locations

United States, Massachusetts
MGH	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Takara Stanley, MD 617-726-5312 tstanley@partners.org
Contact: James Liebau, N.P. 617-724-6926
Principal Investigator: Steven K Grinspoon, MD

Sponsors and Collaborators

Massachusetts General Hospital

Bristol-Myers Squibb

Investigators

Principal Investigator:

Steven K Grinspoon, MD

MGH

More Information

Responsible Party:	Massachusetts General Hospital ( Steven K. Grinspoon, MD )
Study ID Numbers:	2005-P-002239
Study First Received:	December 15, 2006
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00413153
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

HIV
Kaletra
Reyataz
Insulin sensitivity

Lipids
Body Composition
Receiving Kaletra
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Insulin
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009