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Ensayos clínicos

Ensayos clínicos

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

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001118, ACTG P1005
  • Concluido

Propósito del estudio

To obtain preliminary information on the safety, tolerability, and pharmacokinetics of multiple doses of T-20 given as a single subcutaneous (SC) injection, a single intravenous (IV) bolus, and as chronic twice-daily (bid) SC injections. To provide preliminary information on the antiviral activity of T-20 given as chronic bid SC injections in children with viral replication greater than 10,000 copies/ml stable on their initial combination antiretroviral therapy consisting of 2 nucleoside reverse transcriptase inhibitors (NRTIs) alone, or in combination with a nonnucleoside reverse transcriptase inhibitor (NNRTI) or [AS PER AMENDMENT 4/20/00: and/or] a protease inhibitor (PI).

Afección:Fase:
Infecciones por el VIH
Fase 1

Detalles del estudio

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 48.]

Criterios de exclusión

    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.

Centros de estudio/contactos

California

    UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States

    Long Beach Memorial (Pediatric), Long Beach, California, 90801, United States

    Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles, California, 900276016, United States

    UCSF / Moffitt Hosp - Pediatric, San Francisco, California, 941430105, United States

District of Columbia

    Howard Univ Hosp, Washington, District of Columbia, 20060, United States

    Children's Hosp of Washington DC, Washington, District of Columbia, 200102916, United States

Florida

    Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida, 32209, United States

    Univ of Miami (Pediatric), Miami, Florida, 33161, United States

Louisiana

    Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States

Massachusetts

    Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States

    Boston City Hosp / Pediatrics, Boston, Massachusetts, 02118, United States

    Baystate Med Ctr of Springfield, Springfield, Massachusetts, 01199, United States

    Univ of Massachusetts Med School, Worcester, Massachusetts, 016550001, United States

Michigan

    Children's Hosp of Michigan, Detroit, Michigan, 48201, United States

New Jersey

    Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey, 071032714, United States

New York

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

    Bronx Lebanon Hosp Ctr, Bronx, New York, 10457, United States

    North Shore Univ Hosp, Great Neck, New York, 11021, United States

    Harlem Hosp Ctr, New York, New York, 10037, United States

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States

    Metropolitan Hosp Ctr, New York, New York, 10029, United States

    SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York, 13210, United States

North Carolina

    Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States

South Carolina

    Med Univ of South Carolina, Charleston, South Carolina, 294253312, United States

    San Juan City Hosp, San Juan, South Carolina, 009367344, Puerto Rico

Actualizado: 2 de noviembre del 2004

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