Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.
- Conditions
- Cardiovascular DiseaseHIV
- Interventions
- Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
- Registration Number
- NCT01258439
- Lead Sponsor
- St Vincent's Hospital, Sydney
- Brief Summary
This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats.
Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Provision of signed, informed consent
- Age >18 years
- HIV infection documented by HIV antibody test and Western Blot prior to study entry
- No previous ART OR no ART for 6 months prior to randomisation
- CD4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
- No genotypic resistance to Raltegravir, Tenofovir/emtricitabine, Darunavir, Ritonavir
- Body mass index less than 30kg/m2
- Primary HIV infection within the last 6 months
- Active infection or opportunistic illness within the previous 30 days
- Use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
- Use of lipid-lowering therapy
- Diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
- Use of oral prednisolone > 7.5mg daily or equivalent
- pregnancy or Breast feeding
- proven hypersensitivity to one or more components of the study meal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1.Raltegravir plus truvada Darunavir, ritonavir, tenofovir/emtricitabine (Truvada) Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks 2. ritonavir boosted darunavir plus truvada raltegravir plus truvada Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks
- Primary Outcome Measures
Name Time Method To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks 24 weeks Fasting samples will be taken for total cholesterol, LDL and HDL cholesterol, and triglycerides. Repeat lipid samples will be collected before a high fat meal is consumed. After the meal is completed , blood will be collected at 1, 2, 3, and 4 hours at baseline, week 4 and week 24 visits.
- Secondary Outcome Measures
Name Time Method Other metabolic parameters 24 weeks Fasting metabolic parameters will be assessed. Study staff and participants will be blinded to the results fo these tests until completion of the study or parameters become sginificantly abnormal
Arterial stiffness 24 weeks safety 24 weeks Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio
Trial Locations
- Locations (2)
Holdsworth House Medical Practice
🇦🇺Sydney, New South Wales, Australia
St Vincent Hospital, Clinical Research Program
🇦🇺Sydney, New South Wales, Australia