drugset / Trial / NCT01258439

Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.

NCT01258439

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-11
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darunavir Small molecule 800 mg Oral
Comparator Raltegravir Other / unclassified 400 mg Oral
Comparator Ritonavir Other / unclassified 100 mg Oral
Comparator Tenofovir Small molecule 300 mg Oral
Comparator emtricitabine Other / unclassified 200 mg Oral