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

NCT01010399 | Completed Phase 4 Results

• 1 other identifier: COL112948
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertriglyceridemia; HIV Infection

Keywords

HIV; triglycerides; fosamprenavir

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Triglycerides <200 mg/dL

  24 weeks

Secondary Outcomes (1)

• Proportion of Subjects With HIV-1 RNA <50 Copies/mL

  24 weeks

Study Arms (1)

Boosted Lexiva with Lovaza

EXPERIMENTAL

Dietary Supplement: Lovaza; Drug: fosamprenavir/ritonavir

Interventions

Lovaza DIETARY_SUPPLEMENT

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

Boosted Lexiva with Lovaza

fosamprenavir/ritonavir DRUG

Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day

Boosted Lexiva with Lovaza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Felizarta, Franco, M.D.: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Franco Felizarta, MD

Bakersfield, California, 93301, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia; HIV Infections

Interventions

Omacor; fosamprenavir; Ritonavir

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Franco Felizarta, MD
• Organization: Franco Felizarta, MD

felizarta@pol.net

661-324-3128

Study Officials

• Franco Felizarta, MD

  Franco Felizarta, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 10, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 18, 2012
• Results First Posted: April 18, 2012

Record last verified: 2012-03

Locations

US (1)