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Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients

30. oktober 2013 opdateret af: Boehringer Ingelheim

A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic, Efficacy and Safety Parameters of Nevirapine 150mg/m2 and Nevirapine 4 or 7 mg/kg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric Patients.

Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients.

Studieoversigt

Status

Afsluttet

Betingelser

HIV-infektioner

Intervention / Behandling

Detaljeret beskrivelse

A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients.

Primary objective: To evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 in antiretroviral drug naive pediatric patients.

Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg after 24 and 48 weeks of treatment

Study Hypothesis:

Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations. The goal in this study was to determine if a Nevirapine suspension dose of 150 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in adult safety and efficacy trials.

Comparison(s):

ACTG 245

Undersøgelsestype

Interventionel

Tilmelding

123

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Sydafrika
- - Cape Town, Sydafrika, 7900
    - Groote Schuur Hospital
  - Pretoria, Sydafrika
    - Boehringer Ingelheim Investigational Site
  - Soweto, Sydafrika, 2013
    - Boehringer Ingelheim Investigational Site
  - Tygerberg, Sydafrika, 7505
    - Boehringer Ingelheim Investigational Site

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

3 måneder til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion:

Male or female patients between 3 months and 16 years of age at day 28 of the study.
Evidence of HIV-1 infection
Patients who are antiretroviral drug naive
Plasma viral load detectable
CD4 >=50 cells/cc3
Written informed permission
Active assent given by the patient if the child is capable of understanding the given information
Reasonable probability for completion of the trial

Exclusion:

Any significant disease, other than HIV
Any acute illness within 2 weeks prior to Day 0
Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
Patients requiring systematic treatment with CYP3A4 substrates
Patients with malabsorption, severe chronic diarrhea
Receipt of any cytotoxic therapy for malignancy
Current grade 3 or 4 clinical or laboratory toxicity
Pregnancy or breast-feeding
Females of childbearing potential not using adequate contraception. allergy or known drug hypersensitivity to any of the study drugs intravenous drug abuse, alcohol or substance abuse

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	Tidsramme
Area under the concentration-time curve over one dosing interval (AUCτ) Tidsramme: 1, 3 and 6 hours on Day 28	1, 3 and 6 hours on Day 28
Maximum observed concentration (Cmax) Tidsramme: 1, 3 and 6 hours on Day 28	1, 3 and 6 hours on Day 28
Minimum observed concentration (Cmin) Tidsramme: 1, 3 and 6 hours on Day 28	1, 3 and 6 hours on Day 28
Oral clearance (Dose/AUC) at steady state Tidsramme: 1, 3 and 6 hours on Day 28	1, 3 and 6 hours on Day 28

Sekundære resultatmål

Resultatmål	Tidsramme
Change in HIV-1 RNA count Tidsramme: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48	week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Virologic Response Tidsramme: 48 weeks	48 weeks
Time to Virologic Suppression Tidsramme: 48 weeks	48 weeks
Virologic Failure Tidsramme: 48 weeks	48 weeks
Time to Virologic Failure Tidsramme: 48 weeks	48 weeks
Treatment Failure Tidsramme: 48 weeks	48 weeks
Time to Treatment Failure Tidsramme: 48 weeks	48 weeks
Change in CD4+ cell count Tidsramme: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48	week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Change in CD4+ percent Tidsramme: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48	week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Occurrence of Adverse Events Tidsramme: 48 weeks	48 weeks
Occurrence of Rash Tidsramme: 48 weeks	48 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Boehringer Ingelheim

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.

Hjælpsomme links

Related Info

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 2002

Primær færdiggørelse (Faktiske)

1. december 2004

Studieafslutning