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"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects

NCT00114933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-03-21

No results posted yet for this study

Summary

Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.

Conditions

  • HIV Infection

Interventions

DRUG

Stopping nucleosides and continuing lopinavir/ritonavir monotherapy

Sponsors & Collaborators

  • Pulido, Federico, M.D.

    collaborator INDIV

  • Abbott

    collaborator INDUSTRY

  • Arribas, Jose R., M.D.

    lead INDIV

Principal Investigators

  • José R. Arribas, MD · Hospital La Paz

  • Federico Pulido, MD · Hospital 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Completion
2007-05-31

Countries

  • Spain

Study Locations

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Entities

Companies

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 NCT00114933 on ClinicalTrials.gov