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Induction-maintenance of Lopinavir/r in HIV-infected Subjects

NCT00159224 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-09-07

No results posted yet for this study

Summary

This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.

The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1.

Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir/ritonavir simplification strategy

Simplification

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Fundación Huésped

    lead OTHER

Principal Investigators

  • Pedro E Cahn, MD, PhD · Fundacion Huesped, Buenos Aires, Argentina

  • Julio SG Montaner, MD · University of British Columbia

  • Isabel L Cassetti, MD · Helios Salud, Buenos Aires, Argentina

  • Juan Sierra Madero, MD · Instituto Nacional de Ciencias Medicas y Nutricio Salvador Zurbaran, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Argentina
  • Canada
  • Mexico

Study Locations

More Related Trials

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 NCT00159224 on ClinicalTrials.gov