"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects
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
2 other identifiers
interventional
200
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2005
Typical duration for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 20, 2005
CompletedFirst Posted
Study publicly available on registry
June 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 21, 2008
September 1, 2005
June 20, 2005
March 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% patients with therapeutic failure in both arms at 48 weeks (OT and ITT)
Secondary Outcomes (6)
% 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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arribas, Jose R., M.D.lead
- Pulido, Federico, M.D.collaborator
- Abbottcollaborator
Study Sites (28)
Hospital General de Alicante
Alicante, Alicante, 03010, Spain
Hospital General de Elche
Elche, Alicante, 03202, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital Sant Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Clinic i Provincial
Barcelona, Barcelona, 08036, Spain
Hospital Germans Trias i Pujol
Barcelona, Barcelona, 08916, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Insular
Las Palmas de Gran Canaria, Gran Canaria, 35500, Spain
Hospital Virgen de las Nieves
Granada, Granada, 18014, Spain
Hospital de Donostia
San Sebastián, Guipuzcoa, 20014, Spain
Hospital U. Príncipe de Asturias
Alcalá de Henares, Madrid, 28880, Spain
Hospital La Paz
Madrid, Madrid, 28 046, Spain
Hospital La Princesa
Madrid, Madrid, 28006, Spain
Hospital Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Xeral Cies
Vigo, Pontevedra, 362004, Spain
Hospital Virgen Macarena
Seville, Sevilla, 41009, Spain
Hospital Nuestra Señora de Valme (Sevilla)
Seville, Sevilla, 41014, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Hospital La Fe
Valencia, Valencia, 46009, Spain
Hospital Clínico de Valencia
Valencia, Valencia, 46010, Spain
Hospital General de Valencia
Valencia, Valencia, 46014, Spain
Hospital Dr. Peset
Valencia, Valencia, 46017, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, 50010, Spain
Related Publications (2)
Arribas JR, Delgado R, Arranz A, Munoz R, Portilla J, Pasquau J, Perez-Elias MJ, Iribarren JA, Rubio R, Ocampo A, Sanchez-Conde M, Knobel H, Arazo P, Sanz J, Lopez-Aldeguer J, Montes ML, Pulido F; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):147-52. doi: 10.1097/QAI.0b013e3181a56de5.
PMID: 19349870DERIVEDPulido F, Arribas JR, Delgado R, Cabrero E, Gonzalez-Garcia J, Perez-Elias MJ, Arranz A, Portilla J, Pasquau J, Iribarren JA, Rubio R, Norton M; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS. 2008 Jan 11;22(2):F1-9. doi: 10.1097/QAD.0b013e3282f4243b.
PMID: 18097218DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
José R. Arribas, MD
Hospital La Paz
- STUDY CHAIR
Federico Pulido, MD
Hospital 12 de Octubre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
June 20, 2005
First Posted
June 21, 2005
Study Start
January 1, 2005
Study Completion
May 1, 2007
Last Updated
March 21, 2008
Record last verified: 2005-09