NCT01066065

Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

Metabolic Profile and Cardiovascular Biomarker Pattern Compared in naíve Patients Initiating HAART With TDF-FTC and Raltegravir 400mg BID Vs Darunavir 800 mg Plus Ritonavir 100 mg QD; a One Year Follow-up Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Hospital Carlos III, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The advent of new antiretroviral drugs improved the management of HIV naive patients in terms of efficacy. However, the long term metabolic profile of this drugs has not yet been compared and associations between new antiretrovirals and cardiovascular events remains controversial. Moreover, the better tolerability and easy dosage of this new drugs might hypothetically influence adherence and QOL of HIV patients.

Conditions

• Cardiovascular Disease
• HIV Infections

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-02-10
• Last updated: 2010-06-25

Locations

1 site across 1 country: Spain