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

HIV Infection Clinical Trial

— BuLLET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010399
• Other study ID #: COL112948
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2009
• Last updated: March 26, 2012
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2012
• Source: Felizarta, Franco, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• Hypertriglyceridemia

Intervention

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

Locations

Country	Name	City	State
United States	Franco Felizarta, MD	Bakersfield	California

Sponsors (2)

Lead Sponsor	Collaborator
Felizarta, Franco, M.D.	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects With Triglycerides <200 mg/dL		24 weeks	No
Secondary	Proportion of Subjects With HIV-1 RNA <50 Copies/mL		24 weeks	No