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

March 20, 2008 updated by: Arribas, Jose R., M.D.

Phase III-IV, Comparative, Randomized, Open-Label, Study to Evaluate Safety and Efficacy of Suspending Nucleosides From a Triple-Drug Therapy Based on Lopinavir/Ritonavir Versus Continuing Triple-Drug Therapy in HIV-Infected Subjects With Undetectable Plasma HIV Viremia for Six Months

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Study Objective: Efficacy and durability of switching to lopinavir/ritonavir single-drug HAART compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides

Secondary Study Objective(s):

  • Safety (related drug AEs/SAEs and laboratory anomalies G3/4) through 48 w.
  • Resistance profile on patients with sustained virological failure
  • QOL comparing stopping nucleosides versus continuing therapy
  • Pharmaco-economic analysis comparing treatment cost between the 2 study arms.
  • Predicting factors of failure in the stopping nucleosides arm

Subject Population: 200 patients

Study Design:

RANDOMIZATION:

Patients are randomized (1:1) either to continue under the same treatment or stop nucleosides as follows:

  • Stopping nucleosides arm: Lopinavir/r alone.
  • Continuing arm: Lopinavir/r + 2 NRTIs

STUDY PROCEDURES: A baseline HIV-RNA, CD4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study. Patients will be followed for HIV-RNA (and CD4) at w1, w4, w8, w16, w24, w 36 and w48. After w48, durability of response to lopinavir/r single-drug therapy will be studied long-term (up to w96). Routine hematology and clinical chemistry (including fasting triglycerides and cholesterol, total and HDL/LDL ratio) will be measured at w4, w16, w24, w 36 and w48. A central laboratory will be used for HIV-RNA determinations and to archive plasma/cell samples for further genotype test in case of rebound.

Treatment adherence will be followed with a self-patient report questionnaire (GEEMA study)

All AEs will be collected if suspected relation (possible or probable) to any concomitant ARV drug, and SAEs, related or not, reported within 24h.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08025
        • Hospital Sant Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Madrid, Spain, 28 046
        • Hospital La Paz
      • Sevilla, Spain, 41009
        • Hospital Virgen Macarena
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme (Sevilla)
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
      • Valencia, Spain, 46014
        • Hospital General de Valencia
      • Valencia, Spain, 46009
        • Hospital La Fe
      • Valencia, Spain, 46017
        • Hospital Dr. Peset
      • Zaragoza, Spain, 50010
        • Hospital Miguel Servet
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Hospital General de Elche
    • Barcelona
      • Hospitalet de LLobregat, Barcelona, Spain, 08907
        • Hospital de Bellvitge
    • Gran Canaria
      • Las Palmas de Gran Canaria, Gran Canaria, Spain, 35500
        • Hospital Insular
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain, 20014
        • Hospital de Donostia
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28880
        • Hospital U. Príncipe de Asturias
    • Pontevedra
      • Vigo, Pontevedra, Spain, 362004
        • Hospital Xeral Cíes
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Hospital Universitario de Canarias
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV patients > 18 years old who provide signed and dated Informed consent.
  • HIV patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks.
  • Plasma HIV RNA < 50 cop/ml for six months

Exclusion Criteria:

  • HIV patients who have stopped a protease inhibitor due to virological failure.
  • HIV patients with hepatic or renal insufficiency.
  • HIV patients with positive serum HBVAg
  • HIV patients who require treatment with a lopinavir/r contraindicated medication.
  • HIV pregnant or breastfeeding women.
  • Active drug abuse (including alcohol or recreational drugs). Exception, cannabis, provided the investigator is confident in patient adherence. Patients under Methadone program will be accepted too if deemed appropriate by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
% patients with therapeutic failure in both arms at 48 weeks (OT and ITT)

Secondary Outcome Measures

Outcome Measure
% patients with virological failure: HIV-RNA > 500 cop/ml under the randomly assigned therapy (OT and ITT)
% patients with HIV RNA < 500 cop/ml and < 50 cop/ml at w24, w48 (OT and ITT)
Time to virological failure per Kaplan Meyer analysis
CD4 cell count change from baseline
Percentage of viruses with resistance in the protease gene at w24 and w48
Description of AEs with probable, possible or unknown relationship to study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arribas, Jose R., M.D.

Collaborators

Abbott
Pulido, Federico, M.D.

Investigators

  • Study Chair: José R. Arribas, MD, Hospital La Paz
  • Study Chair: Federico Pulido, MD, Hospital 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

June 20, 2005

First Submitted That Met QC Criteria

June 20, 2005

First Posted (Estimate)

June 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 21, 2008

Last Update Submitted That Met QC Criteria

March 20, 2008

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPA-378-05-40
  • EudraCT 2004-001323-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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