Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

NCT ID: NCT01066065

Last Updated: 2010-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Raltegravir Cohort

Patients taking RAL 400 mg BID with Truvada

No interventions assigned to this group

Darunavir Cohort

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* VIH-1

Exclusion Criteria

* pregnancy
* previous Antiretroviral exposure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Carlos III, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Vicente Soriano

Locations

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Hospital Carlos III

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jose Medrano, MD

Role: CONTACT

+34914532531

Other Identifiers

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HCIII0110

Identifier Type: -

Identifier Source: org_study_id

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