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

This study has been completed.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: November 2, 1999
Last updated: May 17, 2012
Last verified: May 2012

November 2, 1999
May 17, 2012
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Complete list of historical versions of study NCT00001118 on Archive Site
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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).

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.]

Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
Drug: Enfuvirtide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2002
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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.
3 Years to 12 Years
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
P1005, 11642, ACTG P1005, PACTG P1005, T20-204
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Joseph Church
Study Chair: Coleen Cunningham
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP