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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114933
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : March 21, 2008
Pulido, Federico, M.D.
Information provided by:
Arribas, Jose R., M.D.

Brief 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.

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

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:


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  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00114933

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 del Mar
Barcelona, Spain, 08003
Hospital Sant Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Germans Trias i Pujol
Barcelona, Spain, 08916
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital La Paz
Madrid, Spain, 28 046
Hospital La Princesa
Madrid, Spain, 28006
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Ramón y Cajal
Madrid, Spain, 28034
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital Nuestra Señora de Valme (Sevilla)
Sevilla, Spain, 41014
Hospital La Fe
Valencia, Spain, 46009
Hospital Clínico de Valencia
Valencia, Spain, 46010
Hospital General de Valencia
Valencia, Spain, 46014
Hospital Dr. Peset
Valencia, Spain, 46017
Hospital Miguel Servet
Zaragoza, Spain, 50010
Sponsors and Collaborators
Arribas, Jose R., M.D.
Pulido, Federico, M.D.
Study Chair: José R. Arribas, MD Hospital La Paz
Study Chair: Federico Pulido, MD Hospital 12 de Octubre

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00114933     History of Changes
Other Study ID Numbers: SPA-378-05-40
EudraCT 2004-001323-37
First Posted: June 21, 2005    Key Record Dates
Last Update Posted: March 21, 2008
Last Verified: September 2005

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors