- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001118
Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children
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).
Study Overview
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.]
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 009367344
- San Juan City Hosp
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California
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La Jolla, California, United States, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
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Long Beach, California, United States, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, United States, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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San Francisco, California, United States, 941430105
- UCSF / Moffitt Hosp - Pediatric
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District of Columbia
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Washington, District of Columbia, United States, 200102916
- Children's Hosp of Washington DC
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Washington, District of Columbia, United States, 20060
- Howard Univ Hosp
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Florida
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Jacksonville, Florida, United States, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, United States, 33161
- Univ of Miami (Pediatric)
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Louisiana
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New Orleans, Louisiana, United States, 701122699
- Tulane Univ / Charity Hosp of New Orleans
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Massachusetts
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Boston, Massachusetts, United States, 021155724
- Children's Hosp of Boston
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Boston, Massachusetts, United States, 02118
- Boston City Hosp / Pediatrics
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Springfield, Massachusetts, United States, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, United States, 016550001
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, United States, 48201
- Children's Hosp of Michigan
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New Jersey
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Newark, New Jersey, United States, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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Bronx, New York, United States, 10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
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Bronx, New York, United States, 10457
- Bronx Lebanon Hosp Ctr
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Great Neck, New York, United States, 11021
- North Shore Univ Hosp
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10029
- Metropolitan Hosp Ctr
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New York, New York, United States, 10037
- Harlem Hosp Ctr
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Syracuse, New York, United States, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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North Carolina
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Durham, North Carolina, United States, 277103499
- Duke Univ Med Ctr
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South Carolina
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Charleston, South Carolina, United States, 294253312
- Med Univ of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Joseph Church
- Study Chair: Coleen Cunningham
Publications and helpful links
General Publications
- Kosel B, Church J, Cunningham C, Sista P, Aweeka F. Pharmacokinetics (PK) of selected doses of T-20, a fusion inhibitor, in HIV-1-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 726)
- Church JA, Cunningham C, Hughes M, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Purdue L, Hawkins E, Sista P; PACTG P1005 Study Team. Pediatric AIDS Clinical Trials Group. Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002 Jul;21(7):653-9. doi: 10.1097/00006454-200207000-00010.
- Soy D, Aweeka FT, Church JA, Cunningham CK, Palumbo P, Kosel BW, Sheiner LB; Pediatric AIDS Clinical Trial Group (PACTG) Study P1005 Investigators. Population pharmacokinetics of enfuvirtide in pediatric patients with human immunodeficiency virus: searching for exposure-response relationships. Clin Pharmacol Ther. 2003 Dec;74(6):569-80. doi: 10.1016/j.clpt.2003.09.002.
- Church JA, Hughes M, Chen J, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Hawkins E, Sista P, Cunningham CK; Pediatric AIDS Clinical Trials Group P1005 Study Team. Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2004 Aug;23(8):713-8. doi: 10.1097/01.inf.0000133045.45316.6a.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Fusion Inhibitors
- Viral Fusion Protein Inhibitors
- Enfuvirtide
Other Study ID Numbers
- P1005
- 11642 (DAIDS ES)
- ACTG P1005
- PACTG P1005
- T20-204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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