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.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: St Vincent's Hospital, Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	raltegravir plus truvada	raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks
DRUG	Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)	Darunavir two 400mg tablets with one ritonavir 100mg capsule once daily plus Tenofovir/emtricitabine (Truvada) one 300mg/200mg tablet once daily with food for 24 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-12-13
• Last updated: 2015-01-12

Locations

2 sites across 1 country: Australia