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Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients

NCT00335686 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2008-02-29

No results posted yet for this study

Summary

The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues.

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h

Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h

DRUG

Nevirapine (Viramune): 1 comp (200mg)/12h

Nevirapine (Viramune): 1 comp (200mg)/12h

Sponsors & Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Bonaventura Clotet, MD,PhD · Lluita contra la Sida Foundation-HIV Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2006-03-31
Completion
2006-03-31

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 NCT00335686 on ClinicalTrials.gov