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

This study has been completed.

First Received: August 11, 2001 Last Updated: November 14, 2005 History of Changes

Sponsor:	Hoffmann-La Roche
Collaborator:	Trimeris
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00022763

Purpose

This study will evaluate T-20 in children.

Condition	Intervention	Phase
HIV Infections	Drug: Enfuvirtide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Safety Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Estimated Enrollment:

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.

Eligibility

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

Criteria

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

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

Locations

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 Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
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

Trimeris

More Information

No publications provided

Study ID Numbers:	NV16056, T20-310, 295E
Study First Received:	August 11, 2001
Last Updated:	November 14, 2005
ClinicalTrials.gov Identifier:	NCT00022763 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:

Anti-HIV Agents
pentafuside

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Enfuvirtide
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009