Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01066065
• Other study ID #: HCIII0110
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2010
• Last updated: June 24, 2010
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2010
• Source: Hospital Carlos III, Madrid
• Contact: Jose Medrano, MD
• Phone: +34914532531
• Email: josemedranolaporte[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• VIH-1

Exclusion Criteria:

• pregnancy

• previous Antiretroviral exposure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• HIV Infections

Locations

Country	Name	City	State
Spain	Hospital Carlos III	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Carlos III, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Insulin resistance defined by HOMA index.		baseline and week 12, 24, 36 and 48	No
Primary	Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs...		baseline and week 12, 24, 36 and 48	No
Secondary	Antiretroviral adherence and quality of life items.		baseline and week 12,24,36,48	No
Secondary	Efficacy defined as viral suppression and CD4 count recovery		baseline and week 12,24,36,48	No