Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001118
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
Study of a New Anti-HIV Drug T-20 in HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study of T-20 a Fusion Inhibitor in HIV-1 Infected Children
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor a protease inhibitor PI
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 andor 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 III open-label dose-escalating randomized study is divided into 2 parts Patients may participate in Part A andor 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 42000 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 12700 48 weeks of treatment optional extension to 48 weeks AS PER AMENDMENT 12700 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 42000 Cohort 1 receives 30 mgm2 SC bid Dose 1 Cohort 2 receives 60 mgm2 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 1600 Abacavir and amprenavir are now allowed The first injection will be given in the clinic and a parentguardian will be trained to give successive injections AS PER AMENDMENT 42000 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 12700 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
This Phase III open-label dose-escalating randomized study is divided into 2 parts Patients may participate in Part A andor 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 42000 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 12700 48 weeks of treatment optional extension to 48 weeks AS PER AMENDMENT 12700 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 42000 Cohort 1 receives 30 mgm2 SC bid Dose 1 Cohort 2 receives 60 mgm2 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 1600 Abacavir and amprenavir are now allowed The first injection will be given in the clinic and a parentguardian will be trained to give successive injections AS PER AMENDMENT 42000 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 12700 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T20-204 | Registry Identifier | DAIDS ES | None |
| 11642 | REGISTRY | None | None |
| ACTG P1005 | None | None | None |
| PACTG P1005 | None | None | None |