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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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: | 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:
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
|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01010399
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
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:
|
Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Fosamprenavir Anti-HIV Agents Anti-Infective Agents |
Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015