HIV Infection Clinical Trial
— BuLLETOfficial 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
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 |
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Franco Felizarta, MD | Bakersfield | California |
Lead Sponsor | Collaborator |
---|---|
Felizarta, Franco, M.D. | GlaxoSmithKline |
United States,
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 |
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