Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects - Full Text View

Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects (BuLLET)

This study is currently recruiting participants.

Verified by Felizarta, Franco, M.D., November 2009

First Received: November 9, 2009 No Changes Posted

Sponsor:	Felizarta, Franco, M.D.
Collaborator:	GlaxoSmithKline
Information provided by:	Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier:	NCT01010399

Purpose

In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in fasting triglycerides < 200 mg /dL while maintaining virologic suppression.

Condition	Intervention	Phase
Hypertriglyceridemia HIV Infection	Dietary Supplement: Lovaza Drug: fosamprenavir/ritonavir	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Pilot, Open-Label Study of Adjunctive Therapy With Lovaza® in Hypertriglyceridemic, HIV-Infected Subjects Who Switched Protease Inhibitor to Once-Daily Lexiva® 1400mg Plus Norvir® 100mg Plus Optimized Background

Resource links provided by NLM:

MedlinePlus related topics: AIDS Triglycerides

Drug Information available for: Ritonavir Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium Omacor

U.S. FDA Resources

Further study details as provided by Felizarta, Franco, M.D.:

Primary Outcome Measures:

Proportion of subjects with triglycerides <200 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with HIV-1 RNA <50 copies/mL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Boosted Lexiva with Lovaza: Experimental	Dietary Supplement: Lovaza Lovaza at a dose of 4g per day with each 1g capsule containing 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) for 18 weeks Drug: fosamprenavir/ritonavir Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

fasting triglycerides >= 200 mg/dL but <1,200 mg/dL
fasting LDL <= 160 mg/dL
participation in a lipid-lowering diet and exercise program for at least 28 days
treatment with stable HAART consisting of first or second RTV-boosted PI regimen plus optimized background ART for at least 3 months
plasma HIV-1 RNA <50 copies/mL
CD4+ cell count >50 cells/mm3
male subjection testosterone replacement therapy with total testosterone level <= 1 x upper limit of normal
female study volunteer must use a form of contraception
ability and willing ness to give written informed consent

Exclusion Criteria:

any Grade 4 laboratory abnormality
currently taking amprenavir or fosamprenavir
required a second RTV-boosted PI for reasons of virologic failure
atherosclerotic disease risk
congestive heart failure (NYHA Class III or IV)
uncontrolled hypertension
history of pancreatitis
active bleeding disorder
recent history of significant renal, pulmonary, biliary, hepatic or gastrointestinal disease
current diabetes mellitus requiring pharmacological treatment
use of systemic cancer chemotherapy; active cancer
pregnancy or breast-feeding
requirement for any lipid-lowering agent after baseline
use of hormonal anabolic therapies, systemic steroids, immune modulators
use of anticoagulants, investigational antiretroviral drugs
allergy to study drugs
active CDC clinical category C event

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010399

Contacts

Contact: Franco Felizarta, MD

(661)-324-3128

felizarta@pol.net

Locations

United States, California
Franco Felizarta, MD	Recruiting
Bakersfield, California, United States, 93301
Contact: Cecilia Felizarta, RN 661-324-3128 cfelizarta@felizartamd.com
Principal Investigator: Franco Felizarta, MD

Sponsors and Collaborators

Felizarta, Franco, M.D.

GlaxoSmithKline

Investigators

Principal Investigator:

Franco Felizarta, MD

More Information

No publications provided

Responsible Party:	Franco Felizarta, MD ( Franco Felizarta, MD )
Study ID Numbers:	COL112948
Study First Received:	November 9, 2009
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT01010399 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Felizarta, Franco, M.D.:

HIV
triglycerides
fosamprenavir

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Dyslipidemias
RNA Virus Infections
HIV Protease Inhibitors
Hypertriglyceridemia
Hyperlipidemias
Metabolic Diseases
Anti-HIV Agents

Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Fosamprenavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010