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

20. marts 2008 opdateret af: Arribas, Jose R., M.D.

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

HIV-infektion

Intervention / Behandling

Medicin: Stopping nucleosides and continuing lopinavir/ritonavir monotherapy

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding

200

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Spanien
- - Alicante, Spanien, 03010
    - Hospital General de Alicante
  - Barcelona, Spanien, 08003
    - Hospital Del Mar
  - Barcelona, Spanien, 08025
    - Hospital Sant Creu i Sant Pau
  - Barcelona, Spanien, 08036
    - Hospital Clinic I Provincial
  - Barcelona, Spanien, 08916
    - Hospital Germans Trías i Pujol
  - Granada, Spanien, 18014
    - Hospital Virgen de las Nieves
  - Madrid, Spanien, 28040
    - Fundación Jiménez Díaz
  - Madrid, Spanien, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spanien, 28034
    - Hospital Ramon y Cajal
  - Madrid, Spanien, 28041
    - Hospital 12 de Octubre
  - Madrid, Spanien, 28007
    - Hospital Gregorio Marañón
  - Madrid, Spanien, 28006
    - Hospital La Princesa
  - Madrid, Spanien, 28 046
    - Hospital La Paz
  - Sevilla, Spanien, 41009
    - Hospital Virgen Macarena
  - Sevilla, Spanien, 41014
    - Hospital Nuestra Señora de Valme (Sevilla)
  - Valencia, Spanien, 46010
    - Hospital Clínico de Valencia
  - Valencia, Spanien, 46014
    - Hospital General de Valencia
  - Valencia, Spanien, 46009
    - Hospital La Fe
  - Valencia, Spanien, 46017
    - Hospital Dr. Peset
  - Zaragoza, Spanien, 50010
    - Hospital Miguel Servet
- Alicante
  - Elche, Alicante, Spanien, 03202
    - Hospital General de Elche
- Barcelona
  - Hospitalet de LLobregat, Barcelona, Spanien, 08907
    - Hospital de Bellvitge
- Gran Canaria
  - Las Palmas de Gran Canaria, Gran Canaria, Spanien, 35500
    - Hospital Insular
- Guipuzcoa
  - San Sebastián, Guipuzcoa, Spanien, 20014
    - Hospital de Donostia
- Madrid
  - Alcalá de Henares, Madrid, Spanien, 28880
    - Hospital U. Príncipe de Asturias
- Pontevedra
  - Vigo, Pontevedra, Spanien, 362004
    - Hospital Xeral Cíes
- Tenerife
  - Santa Cruz de Tenerife, Tenerife, Spanien, 38010
    - Hospital Universitario de Canarias
- Vizcaya
  - Bilbao, Vizcaya, Spanien, 48013
    - Hospital de Basurto

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
% patients with therapeutic failure in both arms at 48 weeks (OT and ITT)

Sekundære resultatmål

Resultatmål
% 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arribas, Jose R., M.D.

Samarbejdspartnere

Abbott

Pulido, Federico, M.D.

Efterforskere

Studiestol: José R. Arribas, MD, Hospital La Paz
Studiestol: Federico Pulido, MD, Hospital 12 de Octubre

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2005

Studieafslutning

1. maj 2007

Datoer for studieregistrering

Først indsendt

20. juni 2005

Først indsendt, der opfyldte QC-kriterier