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

NCT01010399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-04-18

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Franco Felizarta, MD · Franco Felizarta, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01010399 on ClinicalTrials.gov