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:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00022763

First received: August 11, 2001

Last updated: November 14, 2005

Last verified: November 2005

History of Changes

Purpose

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Enfuvirtide

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:


Estimated Enrollment:	48

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

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

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 Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
Mount Sinai Hosp
New York, New York, United States, 10029
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, United States, 10021
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


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

Keywords provided by Hoffmann-La Roche:


Anti-HIV Agents pentafuside

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections	Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases

ClinicalTrials.gov processed this record on February 25, 2015

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