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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 16
Updated:4/21/2016
Start Date:August 2001

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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.

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.
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Gainesville, Florida 32611
(352) 392-3261
University of Florida Gainesville UF has a long history of established programs in international education,...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Bronx, New York 10457
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New York, New York 10029
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