Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

Hospital Carlos III, Madrid

Status: Unknown

Conditions: HIV Infections; Cardiovascular Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01066065

HCIII0110

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• VIH-1

Exclusion criteria

• pregnancy
• previous Antiretroviral exposure

Trial design

120 participants in 2 patient groups

Raltegravir Cohort

Description:

Patients taking RAL 400 mg BID with Truvada

Darunavir Cohort

Description:

Patients taking Darunavir 800 mg QD plus Norvir 100 mg QD with truvada