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Trial to Evaluate Efficacy and Safety of Nevirapine 150mg/m2 Versus 4-7mg/kg With 3TC and ZDV for Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00273975
First received: January 9, 2006
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

trial to evaluate efficacy and safety of nevirapine 150mg/m2 vs 4-7mg/kg in combination with 3TC and ZDV for management of pediatric HIV patients


Condition Intervention Phase
HIV Infections
 Drug: Nevirapine
Drug: Lamivudine
Drug: Zidovudine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Registrational Study for 150 mg/m2 Dose

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Primary endpoint, The dose of nevirapine (150mg/m2, not to exceed 200mg, BID) administered to paediatric patients provides drug plasma levels similar to the nevirapine exposure as observed in adults taking nevirapine 200mg BID

Secondary Outcome Measures:
  • An assessment of the efficacy and safety of 150mg/m2 BID nevirapine and 4/7 mg/kg BID nevirapine

Estimated Enrollment: 123
Estimated Study Completion Date: December 2004
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   3 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

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

Exclusion:

  1. Any significant disease, other than HIV
  2. Any acute illness within 2 weeks prior to Day 0
  3. Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
  4. Patients requiring systematic treatment with CYP3A4 substrates
  5. Patients with malabsorption, severe chronic diarrhea
  6. Receipt of any cytotoxic therapy for malignancy
  7. Current grade 3 or 4 clinical or laboratory toxicity
  8. Pregnancy or breast-feeding
  9. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273975

Locations
South Africa
Groote Schuur Hospital
Cape Town, South Africa, 7900
Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Boehringer Ingelheim Investigational Site
Soweto, South Africa, 2013
Boehringer Ingelheim Investigational Site
Tygerberg, South Africa, 7505
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. South Africa (Pty.) Ltd.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00273975     History of Changes
Other Study ID Numbers: 1100.1368
Study First Received: January 9, 2006
Last Updated: May 18, 2012
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Nevirapine
 Lamivudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013