NCT00273975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Jan 2002

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

2.9 years

First QC Date

January 9, 2006

Last Update Submit

October 30, 2013

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

  • Area under the concentration-time curve over one dosing interval (AUCτ)

    1, 3 and 6 hours on Day 28

  • Maximum observed concentration (Cmax)

    1, 3 and 6 hours on Day 28

  • Minimum observed concentration (Cmin)

    1, 3 and 6 hours on Day 28

  • Oral clearance (Dose/AUC) at steady state

    1, 3 and 6 hours on Day 28

Secondary Outcomes (11)

  • Change in HIV-1 RNA count

    week 2, 4, 8, 12, 18, 24, 30, 36, 42,48

  • Virologic Response

    48 weeks

  • Time to Virologic Suppression

    48 weeks

  • Virologic Failure

    48 weeks

  • Time to Virologic Failure

    48 weeks

  • +6 more secondary outcomes

Interventions

NevirapineDRUG
LamivudineDRUG
ZidovudineDRUG

Eligibility Criteria

Age3 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Groote Schuur Hospital

Cape Town, 7900, South Africa

Location

Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

Boehringer Ingelheim Investigational Site

Soweto, 2013, South Africa

Location

Boehringer Ingelheim Investigational Site

Tygerberg, 7505, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

NevirapineLamivudineZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Officials

  • Boehringer Ingelheim Study Coordinator

    B.I. South Africa (Pty.) Ltd.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

January 1, 2002

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations

ZA(4)