Status:
COMPLETED
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.
Lead Sponsor:
St Vincent's Hospital, Sydney
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 har...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01258439
Start Date
November 1 2010
End Date
July 1 2014
Last Update
January 12 2015
Active Locations (2)
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1
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
2
St Vincent Hospital, Clinical Research Program
Sydney, New South Wales, Australia, 2010