Phase 4
N=36
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
Hypertriglyceridemia · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT01010399 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Proportion of Subjects With Triglycerides <200 mg/dL — 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lovaza (Dietary_supplement); fosamprenavir/ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Felizarta, Franco, M.D.
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Triglycerides <200 mg/dL |
12 | — |
| SECONDARY Proportion of Subjects With HIV-1 RNA <50 Copies/mL |
28 | — |
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.
Eligibility Criteria
Inclusion Criteria
- fasting triglycerides >= 200 mg/dL but 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
Data sourced from ClinicalTrials.gov (NCT01010399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.