Last reviewed · How we verify
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.
Details
| Lead sponsor | Hospital Carlos III, Madrid |
|---|---|
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2010-02 |
| Completion | 2011-01 |
Conditions
- Cardiovascular Disease
- HIV Infections
Primary outcomes
- 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
Countries
Spain