Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

• Conditions: Cardiovascular Disease; HIV Infections

• Registration Number: NCT01066065
• Lead Sponsor: Hospital Carlos III, Madrid

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-25
• Primary Completion: 2011-01
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• VIH-1

Exclusion Criteria

• pregnancy
• previous Antiretroviral exposure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lipid profile defined as a clinically significant increment (delta) in Total cholesterol LDL, HDL y non-LDL cholesterol.	baseline and week 12, 24, 36 and 48
Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs...	baseline and week 12, 24, 36 and 48
Insulin resistance defined by HOMA index.	baseline and week 12, 24, 36 and 48

Secondary Outcome Measures

Name	Time	Method
Efficacy defined as viral suppression and CD4 count recovery	baseline and week 12,24,36,48
Antiretroviral adherence and quality of life items.	baseline and week 12,24,36,48

Trial Locations

Locations (1)

Hospital Carlos III; 🇪🇸 Madrid, Spain