Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
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ClinicalTrials.gov Identifier: NCT00001118 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 21, 2012
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Enfuvirtide | Phase 1 |
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 : | Interventional (Clinical Trial) |
Enrollment : | 24 participants |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children |
Actual Study Completion Date : | December 2002 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001118
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 |
Study Chair: | Joseph Church | ||
Study Chair: | Coleen Cunningham |
Publications of Results:
Other Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001118 History of Changes |
Other Study ID Numbers: |
P1005 11642 ( Registry Identifier: DAIDS ES ) ACTG P1005 PACTG P1005 T20-204 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | May 21, 2012 |
Last Verified: | May 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Enfuvirtide HIV Fusion Inhibitors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |