Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects (BuLLET)
This study has been completed.
Sponsor:
Felizarta, Franco, M.D.
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
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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: | Endpoint Classification: Efficacy Study 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:
Genetics Home Reference related topics:
complement factor I deficiency
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 ] [ 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 ]
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
|
![](https://webarchive.library.unt.edu/web/20130305102351im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
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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 |
![](https://webarchive.library.unt.edu/web/20130305102351im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
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 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Felizarta, Franco, M.D.:
HIV triglycerides fosamprenavir |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hypertriglyceridemia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Protease Inhibitors Ritonavir Fosamprenavir Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2013