Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00001118
- Brief Summary
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).
- 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. \[AS PER AMENDMENT 12/7/00: Patients participating in Part B are evaluated at the clinic 6 times during the first 3 weeks, every 4 weeks through Week 24, and then every 8 weeks through Week 48.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States