"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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Stopping nucleosides and continuing lopinavir/ritonavir monotherapy||Phase 4|
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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- % patients with therapeutic failure in both arms at 48 weeks (OT and ITT)
- % 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
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
|Study Chair:||José R. Arribas, MD||Hospital La Paz|
|Study Chair:||Federico Pulido, MD||Hospital 12 de Octubre|