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

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; Cardiovascular Disease

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Jose Medrano, MD; Phone Number: +34914532531; Email: josemedranolaporte@hotmail.com

Study Locations

• Spain
  • Madrid, Spain, 28029
    • Recruiting
    • Hospital Carlos III

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive naïve patients regularly attended at a referral outclinic. 1:1 Randomization in two arms by a local electronic process.

Description

Inclusion Criteria:

• VIH-1

Exclusion Criteria:

• pregnancy
• previous Antiretroviral exposure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Raltegravir Cohort; Patients taking RAL 400 mg BID with Truvada
Darunavir Cohort; Patients taking Darunavir 800 mg QD plus Norvir 100 mg QD with truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Insulin resistance defined by HOMA index.	baseline and week 12, 24, 36 and 48
Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs...	baseline and week 12, 24, 36 and 48

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Carlos III, Madrid

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 10, 2010

Study Record Updates

• Last Update Posted (Estimate): June 25, 2010
• Last Update Submitted That Met QC Criteria: June 24, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: HIV; cardiovascular disease; metabolic disorder; HIV naive patients initiating HAART with Raltegravir or boosted Darunavir
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: HCIII0110