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"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.
 
ClinicalTrials.gov Identifier: NCT00114933
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : March 21, 2008
Sponsor:
Collaborators:
Pulido, Federico, M.D.
Abbott
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:

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.

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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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00114933


Locations
Show Show 28 study locations
Sponsors and Collaborators
Arribas, Jose R., M.D.
Pulido, Federico, M.D.
Abbott
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00114933    
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.:
HIV
AIDS
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
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