Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects (BuLLET)
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ClinicalTrials.gov Identifier: NCT01010399 |
Recruitment Status
:
Completed
First Posted
: November 10, 2009
Results First Posted
: April 18, 2012
Last Update Posted
: April 18, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertriglyceridemia HIV Infection | Dietary Supplement: Lovaza Drug: fosamprenavir/ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
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
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- Proportion of Subjects With Triglycerides <200 mg/dL [ Time Frame: 24 weeks ]
- Proportion of Subjects With HIV-1 RNA <50 Copies/mL [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010399
United States, California | |
Franco Felizarta, MD | |
Bakersfield, California, United States, 93301 |
Principal Investigator: | Franco Felizarta, MD | Franco Felizarta, MD |
Responsible Party: | Felizarta, Franco, M.D. |
ClinicalTrials.gov Identifier: | NCT01010399 History of Changes |
Other Study ID Numbers: |
COL112948 |
First Posted: | November 10, 2009 Key Record Dates |
Results First Posted: | April 18, 2012 |
Last Update Posted: | April 18, 2012 |
Last Verified: | March 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 |