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Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

NCT00759070 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-02-22

No results posted yet for this study

Summary

This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir + emtricitabine + efavirenz

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) \+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily

DRUG

Tenofovir + emtricitabine + lopinavir/ritonavir

Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Hospital Universitari Joan XXIII de Tarragona.

    collaborator OTHER

  • Hospitales Universitarios Virgen del Rocío

    collaborator OTHER

  • Juan A. Arnaiz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00759070 on ClinicalTrials.gov