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Clinical Trials

MainTitle

Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00001118

First received: November 2, 1999
Last updated: May 17, 2012
Last Verified: May 2012
History of Changes
Purpose

Purpose

The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children.

T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).

Condition Intervention Phase
HIV Infections

Drug : Enfuvirtide
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 24
Study Completion Date: December 2002

Detailed Description:

T-20 is the first drug to be developed which specifically inhibits the function of the gp41 transmembrane glycoprotein. By inhibiting the essential protein-protein surface interaction, T-20 is able to block the process of virus-to-host cell membrane fusion. Combination antiretroviral regimens (reverse transcriptase inhibitors plus PIs) have benefited many HIV patients, but heavily pretreated patients often develop multi-drug resistance via multiple gene mutations. A pharmacologic agent, such as T-20, that is effective at an alternative point in the virus replication cycle will make a valuable addition to the treatment of HIV infection.
This Phase I/II open-label, dose-escalating, randomized study is divided into 2 parts. Patients may participate in Part A and/or Part B. Part A (single dosing): 12 patients are sequentially assigned to receive 1 of 3 doses of T-20 given once on Day 0 by SC injection into the abdomen, deltoid area, or anterior aspect of the thigh and once on Day 1 by IV infusion. Provided safety criteria are met, patients who complete Part A, or new enrollees who did not participate in Part A, enroll in Part B. Doses for Part B are determined by pharmacokinetic data obtained in Part A. [AS PER AMENDMENT 4/20/00: Current data has now projected a pediatric dose. Each child will move to chronic dosing in Part B provided the child has no Grade 3 or higher toxicity to study drug through Day 7 in Part A.] Part B (multiple dosing): Patients are randomly assigned to 1 of 3 dose cohorts to receive 24 weeks [AS PER AMENDMENT 12/7/00: 48 weeks] of treatment (optional extension to 48 weeks [AS PER AMENDMENT 12/7/00: 96 weeks]) with bid SC injections of T-20. Cohort 1 receives the dose identified in Part A (Dose 1) as the lowest dose that is well tolerated and that achieves the target trough plasma concentration. Cohort 2 receives the next higher dose from Dose 1 (Dose 2). Cohort 3 receives either Dose 1 or Dose 2, depending on the tolerability and antiviral activity of each dose. [AS PER AMENDMENT 4/20/00: Cohort 1 receives 30 mg/m2 SC bid (Dose 1); Cohort 2 receives 60 mg/m2 SC bid (Dose 2); and Cohort 3 receives Dose 1 or 2 SC bid.] On Day 7 of T-20 dosing, children begin a new antiretroviral therapy regimen chosen by the site investigator based on study parameters. (Abacavir and amprenavir are not allowed for this regimen.) [AS PER AMENDMENT 1/6/00: Abacavir and amprenavir are now allowed.] The first injection will be given in the clinic and a parent/guardian will be trained to give successive injections. [AS PER AMENDMENT 4/20/00: The 2 doses given prior to obtaining trough levels on Days 1 and 7 must be directly observed by medical personnel.] Patients undergo clinical and laboratory evaluations to monitor viral load, HIV-related symptoms, and pharmacokinetics at time points throughout the study. Patients participating in Part A are evaluated at the clinic on Days 0, 1, and 7. Patients participating in Part B are evaluated at the clinic 6 times during the first 3 weeks and then every 4 weeks through Week 24. [AS PER AMENDMENT 12/7/00: Patients participating in Part B are evaluated at the clinic 6 times during the first 3 weeks, every 4 weeks through Week 24, and then every 8 weeks through Week

    Eligibility

    Eligibility

    Ages Eligible for Study: 3 Years to 12 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria
    Children may be eligible for this study if they:

    • Are 3 to 12 years old (consent of parent or guardian required).
    • Are HIV-positive.
    • Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)
    • Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.
    • Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)
    • Have never taken at least 1 NRTI.

    • Exclusion Criteria
      Children will not be eligible for this study if they:
    • Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.
    • Are receiving chemotherapy for cancer.
    • Have certain serious diseases (other than HIV) or conditions.
    • Have received or are currently receiving certain medications.
    • Are pregnant.

    contacts and locations

    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: NCT00001118

    Locations

    United States, California
    UCSD Med Ctr / Pediatrics / Clinical Sciences
    La Jolla, California, United States, 920930672
    Long Beach Memorial (Pediatric)
    Long Beach, California, United States, 90801
    Children's Hosp of Los Angeles/UCLA Med Ctr
    Los Angeles, California, United States, 900276016
    UCSF / Moffitt Hosp - Pediatric
    San Francisco, California, United States, 941430105
    United States, District of Columbia
    Children's Hosp of Washington DC
    Washington, District of Columbia, United States, 200102916
    Howard Univ Hosp
    Washington, District of Columbia, United States, 20060
    United States, Florida
    Univ of Florida Health Science Ctr / Pediatrics
    Jacksonville, Florida, United States, 32209
    Univ of Miami (Pediatric)
    Miami, Florida, United States, 33161
    United States, Louisiana
    Tulane Univ / Charity Hosp of New Orleans
    New Orleans, Louisiana, United States, 701122699
    United States, Massachusetts
    Children's Hosp of Boston
    Boston, Massachusetts, United States, 021155724
    Boston City Hosp / Pediatrics
    Boston, Massachusetts, United States, 02118
    Baystate Med Ctr of Springfield
    Springfield, Massachusetts, United States, 01199
    Univ of Massachusetts Med School
    Worcester, Massachusetts, United States, 016550001
    United States, Michigan
    Children's Hosp of Michigan
    Detroit, Michigan, United States, 48201
    United States, New Jersey
    Univ of Medicine & Dentistry of New Jersey / Univ Hosp
    Newark, New Jersey, United States, 071032714
    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
    North Shore Univ Hosp
    Great Neck, New York, United States, 11021
    Bellevue Hosp / New York Univ Med Ctr
    New York, New York, United States, 10016
    Metropolitan Hosp Ctr
    New York, New York, United States, 10029
    Harlem Hosp Ctr
    New York, New York, United States, 10037
    SUNY Health Sciences Ctr at Syracuse / Pediatrics
    Syracuse, New York, United States, 13210
    United States, North Carolina
    Duke Univ Med Ctr
    Durham, North Carolina, United States, 277103499
    United States, South Carolina
    Med Univ of South Carolina
    Charleston, South Carolina, United States, 294253312
    Puerto Rico
    San Juan City Hosp
    San Juan, Puerto Rico, 009367344

    Sponsors and Collaborators

    National Institute of Allergy and Infectious Diseases (NIAID)
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    Study Chair: Joseph Church
    Study Chair: Coleen Cunningham
    More Information

    More Information


    Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
    ClinicalTrials.gov Identifier: NCT00001118   History of Changes  
    Other Study ID Numbers: P1005  
      11642  
      ACTG P1005  
      PACTG P1005  
      T20-204  
    Study First Received: November 2, 1999  
    Last Updated: May 17, 2012  

    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

    Injections, Intravenous
    Injections, Subcutaneous
    Drug Therapy, Combination
    HIV Protease Inhibitors
    Membrane Fusion
    Reverse Transcriptase Inhibitors
    Anti-HIV Agents
    Viral Load
    peptide T20

    Additional relevant MeSH terms:
    HIV Infections
    Enfuvirtide

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.