Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
Phase 4
Completed
- Conditions
- HypertriglyceridemiaHIV Infection
- Interventions
- Dietary Supplement: Lovaza
- Registration Number
- NCT01010399
- Lead Sponsor
- Felizarta, Franco, M.D.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Boosted Lexiva with Lovaza Lovaza - Boosted Lexiva with Lovaza fosamprenavir/ritonavir -
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Triglycerides <200 mg/dL 24 weeks
- Secondary Outcome Measures
Name Time Method Proportion of Subjects With HIV-1 RNA <50 Copies/mL 24 weeks
Trial Locations
- Locations (1)
Franco Felizarta, MD
🇺🇸Bakersfield, California, United States