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

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Felizarta, Franco, M.D.

ClinicalTrials.gov Identifier:

NCT01010399

First received: November 9, 2009

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

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 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: HIV/AIDS Triglycerides

Drug Information available for: Ritonavir Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium Omega-3-acid ethyl esters Lovaza

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 ]

Secondary Outcome Measures:

Proportion of Subjects With HIV-1 RNA <50 Copies/mL [ Time Frame: 24 weeks ]


Enrollment:	36
Study Start Date:	September 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Boosted Lexiva with Lovaza	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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, California
Franco Felizarta, MD
Bakersfield, California, United States, 93301

Sponsors and Collaborators

Felizarta, Franco, M.D.

GlaxoSmithKline

Investigators


Principal Investigator:	Franco Felizarta, MD	Franco Felizarta, MD

More Information


Responsible Party:	Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier:	NCT01010399 History of Changes
Other Study ID Numbers:	COL112948
Study First Received:	November 9, 2009
Results First Received:	March 26, 2012
Last Updated:	March 26, 2012

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


HIV triglycerides fosamprenavir

Additional relevant MeSH terms:


HIV Infections Hypertriglyceridemia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders	Metabolic Diseases Ritonavir Fosamprenavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 28, 2017

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