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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: August 11, 2001
Last updated: October 27, 2015
Last verified: October 2015
This study will evaluate T-20 in children.

Condition Intervention Phase
HIV Infections
Drug: Enfuvirtide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Estimated Enrollment: 48
Study Start Date: August 2001
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022763

United States, California
Children's Hosp Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
Univ of Florida Gainesville
Gainesville, Florida, United States, 32610
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, United States, 10021
Mount Sinai Hosp
New York, New York, United States, 10029
United States, Virginia
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00022763     History of Changes
Other Study ID Numbers: NV16056  T20-310  295E 
Study First Received: August 11, 2001
Last Updated: October 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 10, 2016