Hypertriglyceridemia, HIV Infection
Conditions
Keywords
HIV, triglycerides, fosamprenavir
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.
Interventions
DIETARY_SUPPLEMENTLovaza
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
Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day
Sponsors
GlaxoSmithKline
Felizarta, Franco, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects With Triglycerides <200 mg/dL | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Subjects With HIV-1 RNA <50 Copies/mL | 24 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Boosted Lexiva With Lovaza | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Boosted Lexiva With Lovaza |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age Continuous | 48.3 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Proportion of Subjects With Triglycerides <200 mg/dL
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boosted Lexiva With Lovaza | Proportion of Subjects With Triglycerides <200 mg/dL | 12 participants |
Secondary
Proportion of Subjects With HIV-1 RNA <50 Copies/mL
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boosted Lexiva With Lovaza | Proportion of Subjects With HIV-1 RNA <50 Copies/mL | 28 participants |