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

Primary Purpose

Hypertriglyceridemia, HIV Infection

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lovaza

fosamprenavir/ritonavir

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring HIV, triglycerides, fosamprenavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Franco Felizarta, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boosted Lexiva with Lovaza

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Subjects With Triglycerides <200 mg/dL

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01010399

First Posted

November 9, 2009

Last Updated

March 26, 2012

Sponsor

Felizarta, Franco, M.D.

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01010399

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Felizarta, Franco, M.D.

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia, HIV Infection

Keywords

HIV, triglycerides, fosamprenavir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Boosted Lexiva with Lovaza

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Lovaza

Intervention Description

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

Drug

Intervention Name(s)

fosamprenavir/ritonavir

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of Subjects With Triglycerides <200 mg/dL

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franco Felizarta, MD

Organizational Affiliation

Franco Felizarta, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Franco Felizarta, MD

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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