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

NCT ID: NCT01010399

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Boosted Lexiva with Lovaza

Group Type: EXPERIMENTAL

Lovaza

Intervention Type: 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

fosamprenavir/ritonavir

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

fosamprenavir/ritonavir

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Felizarta, Franco, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franco Felizarta, MD

Role: PRINCIPAL_INVESTIGATOR

Franco Felizarta, MD

Locations

Franco Felizarta, MD

Bakersfield, California, United States

Countries

United States

Other Identifiers

COL112948

Identifier Type: -

Identifier Source: org_study_id