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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infection

Keywords

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HIV AIDS Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Stopping nucleosides and continuing lopinavir/ritonavir monotherapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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José R. Arribas, MD

Role: STUDY_CHAIR

Hospital La Paz

Federico Pulido, MD

Role: STUDY_CHAIR

Hospital 12 de Octubre

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED

PMID: 19349870 (View on PubMed)

Pulido 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.

Reference Type DERIVED

PMID: 18097218 (View on PubMed)

Other Identifiers

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EudraCT 2004-001323-37

Identifier Type: -

Identifier Source: secondary_id

SPA-378-05-40

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Stopping nucleosides and continuing lopinavir/ritonavir monotherapy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pulido, Federico, M.D.

Abbott

Arribas, Jose R., M.D.

Principal Investigators

José R. Arribas, MD

Federico Pulido, MD

Locations

Hospital General de Alicante

Hospital General de Elche

Hospital del Mar

Hospital Sant Creu i Sant Pau

Hospital Clinic i Provincial

Hospital Germans Trias i Pujol

Hospital de Bellvitge

Hospital Insular

Hospital Virgen de las Nieves

Hospital de Donostia

Hospital U. Príncipe de Asturias

Hospital La Paz

Hospital La Princesa

Hospital Gregorio Marañón

Hospital Ramón y Cajal

Fundación Jiménez Díaz

Hospital Clínico San Carlos

Hospital 12 de Octubre

Hospital Xeral Cies

Hospital Virgen Macarena

Hospital Nuestra Señora de Valme (Sevilla)

Hospital Universitario de Canarias

Hospital La Fe

Hospital Clínico de Valencia

Hospital General de Valencia

Hospital Dr. Peset

Hospital de Basurto

Hospital Miguel Servet

Countries

References

Other Identifiers

EudraCT 2004-001323-37

SPA-378-05-40