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

Tracking Information
First Received Date ^ICMJE	August 11, 2001
Last Updated Date	November 14, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00022763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
Official Title ^ICMJE	A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents
Brief Summary	This study will evaluate T-20 in children.
Detailed Description	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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Enfuvirtide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	3 Years to 16 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00022763
Responsible Party
Study ID Numbers ^ICMJE	NV16056, T20-310, 295E
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE	Trimeris
Investigators ^ICMJE
Information Provided By	Hoffmann-La Roche
Verification Date	November 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP