T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00022763
First received: August 11, 2001
Last updated: October 27, 2015
Last verified: October 2015

August 11, 2001
October 27, 2015
August 2001
December 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00022763 on ClinicalTrials.gov Archive Site
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T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents
This study will evaluate T-20 in children.
Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.
Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
Drug: Enfuvirtide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
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December 2004   (final data collection date for primary outcome measure)

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are 3 through 16 years of age and have the consent of parent or guardian.
  • Have a viral load of at least 5000 copies/ml.
  • Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
  • Have been on stable therapy for at least 4 weeks.
Both
3 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022763
NV16056, T20-310, 295E
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Hoffmann-La Roche
Hoffmann-La Roche
Trimeris
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Hoffmann-La Roche
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP