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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01066065

Enrollment

120

Registered

2010-02-10

Start date

2010-02-28

Completion date

2011-01-31

Last updated

2010-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, HIV Infections

Keywords

cardiovascular disease, HIV, metabolic disorder, HIV naive patients initiating HAART with Raltegravir or boosted Darunavir

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* VIH-1

Exclusion criteria

* pregnancy * previous Antiretroviral exposure

Design outcomes

Primary

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

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

Countries

Spain

Contacts

Primary ContactJose Medrano, MD

josemedranolaporte@hotmail.com+34914532531

Outcome results