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

This study has been completed.
Sponsor:
Collaborators:
Pulido, Federico, M.D.
Abbott
Information provided by:
Arribas, Jose R., M.D.
ClinicalTrials.gov Identifier:
NCT00114933
First received: June 20, 2005
Last updated: March 20, 2008
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Stopping nucleosides and continuing lopinavir/ritonavir monotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Arribas, Jose R., M.D.:

Primary Outcome Measures:
  • % patients with therapeutic failure in both arms at 48 weeks (OT and ITT)

Secondary Outcome Measures:
  • % 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

Estimated Enrollment: 200
Study Start Date: January 2005
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114933

Locations
Spain
Hospital General de Elche
Elche, Alicante, Spain, 03202
Hospital de Bellvitge
Hospitalet de LLobregat, Barcelona, Spain, 08907
Hospital Insular
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35500
Hospital de Donostia
San Sebastián, Guipuzcoa, Spain, 20014
Hospital U. Príncipe de Asturias
Alcalá de Henares, Madrid, Spain, 28880
Hospital Xeral Cies
Vigo, Pontevedra, Spain, 362004
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Hospital de Basurto
Bilbao, Vizcaya, Spain, 48013
Hospital General de Alicante
Alicante, Spain, 03010
Hospital Sant Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Germans Trias i Pujol
Barcelona, Spain, 08916
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital La Princesa
Madrid, Spain, 28006
Hospital La Paz
Madrid, Spain, 28 046
Hospital Nuestra Señora de Valme (Sevilla)
Sevilla, Spain, 41014
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital General de Valencia
Valencia, Spain, 46014
Hospital Clínico de Valencia
Valencia, Spain, 46010
Hospital Dr. Peset
Valencia, Spain, 46017
Hospital La Fe
Valencia, Spain, 46009
Hospital Miguel Servet
Zaragoza, Spain, 50010
Sponsors and Collaborators
Arribas, Jose R., M.D.
Pulido, Federico, M.D.
Abbott
Investigators
Study Chair: José R. Arribas, MD Hospital La Paz
Study Chair: Federico Pulido, MD Hospital 12 de Octubre
  More Information

Additional Information:
No publications provided by Arribas, Jose R., M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00114933     History of Changes
Other Study ID Numbers: SPA-378-05-40, EudraCT 2004-001323-37
Study First Received: June 20, 2005
Last Updated: March 20, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Arribas, Jose R., M.D.:
HIV
AIDS
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lopinavir
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014