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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00273975
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : October 31, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nevirapine Drug: Lamivudine Drug: Zidovudine Phase 2

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.


ACTG 245

Study Type : Interventional  (Clinical Trial)
Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2002
Actual Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Area under the concentration-time curve over one dosing interval (AUCτ) [ Time Frame: 1, 3 and 6 hours on Day 28 ]
  2. Maximum observed concentration (Cmax) [ Time Frame: 1, 3 and 6 hours on Day 28 ]
  3. Minimum observed concentration (Cmin) [ Time Frame: 1, 3 and 6 hours on Day 28 ]
  4. Oral clearance (Dose/AUC) at steady state [ Time Frame: 1, 3 and 6 hours on Day 28 ]

Secondary Outcome Measures :
  1. Change in HIV-1 RNA count [ Time Frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48 ]
  2. Virologic Response [ Time Frame: 48 weeks ]
  3. Time to Virologic Suppression [ Time Frame: 48 weeks ]
  4. Virologic Failure [ Time Frame: 48 weeks ]
  5. Time to Virologic Failure [ Time Frame: 48 weeks ]
  6. Treatment Failure [ Time Frame: 48 weeks ]
  7. Time to Treatment Failure [ Time Frame: 48 weeks ]
  8. Change in CD4+ cell count [ Time Frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48 ]
  9. Change in CD4+ percent [ Time Frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48 ]
  10. Occurrence of Adverse Events [ Time Frame: 48 weeks ]
  11. Occurrence of Rash [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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


  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00273975

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
Study Chair: Boehringer Ingelheim Study Coordinator B.I. South Africa (Pty.) Ltd. Identifier: NCT00273975     History of Changes
Other Study ID Numbers: 1100.1368
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers