Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000876
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase III Trial of CD4-IgG2 in HIV-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:
CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells cells of the immune system that fight infection The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective
HIV attaches to CD4 cells and enters them Inside HIV makes copies of itself that will help the virus invade the body CD4 cells are killed or disabled during this process of HIV replication Decreases in CD4 cells lead to a weakened immune system When CD4 cell counts become very low the body is unable to defend itself and HIV infection develops into AIDS The protein used in this study CD4-IgG2 may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children
HIV attaches to CD4 cells and enters them Inside HIV makes copies of itself that will help the virus invade the body CD4 cells are killed or disabled during this process of HIV replication Decreases in CD4 cells lead to a weakened immune system When CD4 cell counts become very low the body is unable to defend itself and HIV infection develops into AIDS The protein used in this study CD4-IgG2 may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children
Detailed Description:
Since CD4 is the high-affinity receptor for HIV-1 molecules such as CD4-IgG2 which incorporate the gp120 binding region of CD4 have the potential to bind and neutralize all strains of the virus AS PER AMENDMENT 42500 Study results have demonstrated that the product is safe in children well tolerated and may have antiviral properties With these encouraging results in hand an extra cohort has been added using twice the dose of rCD4-IgG2 as in Cohort I
The study is conducted in two parts In Part 1 patients receive a single dose of CD4-IgG2 intravenously at 1 of 4 dose levels A minimum of 3 patients are treated at a given dose level If none of these 3 patients experience Grade 3 or 4 toxicity patients are escalated to the next dose level If any of these 3 patients have life-threatening toxicities or if more than 1 of these 3 patients experience non-life-threatening Grade 3 or 4 toxicities escalation stops and the prior dose if any is considered the maximum tolerated dose MTD If 1 of these 3 patients experiences non-life-threatening Grade 3 or 4 toxicities 3 additional patients are treated at this dose level If 1 or more of these 3 additional patients has Grade 3 or 4 toxicity escalation stops If none of these 3 additional patients has Grade 3 or 4 toxicity patients are escalated to the next dose level
Part 2 provides additional data on the safety toxicity and pharmacokinetics of CD4-IgG2 when given in multiple doses Patients receive the highest safe dose MTD as established in Part 1 Treatment is given intravenously once weekly at Weeks 0 1 2 and 3 If insufficient activity is seen at this dose level 6 additional patients will be enrolled at a higher dose level Patients who participate in Part 1 may enroll in Part 2 provided they are followed for at least 3 months and meet inclusion criteria for Part 2 If any patient experiences a life-threatening condition due to CD4-IgG2 the study will stop AS PER AMENDMENT 42500 Cohort II receives twice the dose of Cohort I intravenously once weekly at Weeks 0 1 2 and 3 Pharmacokinetic samples are obtained at pre-dose and 1 hour after the doses are administered at Weeks 0 1 and 2 and pre-dose 1 hour 24 hours and Days 3 7 and 14 after the dose are administered at Week 3 An overnight stay in the hospital is recommended for the first 24 hours At Weeks 0 1 2 and 3 virology testing including HIV-1 RNA is performed with each infusion of CD4-IgG Follow-up monitoring of patients is done once a month for 4 months for patients in Cohort II
The study is conducted in two parts In Part 1 patients receive a single dose of CD4-IgG2 intravenously at 1 of 4 dose levels A minimum of 3 patients are treated at a given dose level If none of these 3 patients experience Grade 3 or 4 toxicity patients are escalated to the next dose level If any of these 3 patients have life-threatening toxicities or if more than 1 of these 3 patients experience non-life-threatening Grade 3 or 4 toxicities escalation stops and the prior dose if any is considered the maximum tolerated dose MTD If 1 of these 3 patients experiences non-life-threatening Grade 3 or 4 toxicities 3 additional patients are treated at this dose level If 1 or more of these 3 additional patients has Grade 3 or 4 toxicity escalation stops If none of these 3 additional patients has Grade 3 or 4 toxicity patients are escalated to the next dose level
Part 2 provides additional data on the safety toxicity and pharmacokinetics of CD4-IgG2 when given in multiple doses Patients receive the highest safe dose MTD as established in Part 1 Treatment is given intravenously once weekly at Weeks 0 1 2 and 3 If insufficient activity is seen at this dose level 6 additional patients will be enrolled at a higher dose level Patients who participate in Part 1 may enroll in Part 2 provided they are followed for at least 3 months and meet inclusion criteria for Part 2 If any patient experiences a life-threatening condition due to CD4-IgG2 the study will stop AS PER AMENDMENT 42500 Cohort II receives twice the dose of Cohort I intravenously once weekly at Weeks 0 1 2 and 3 Pharmacokinetic samples are obtained at pre-dose and 1 hour after the doses are administered at Weeks 0 1 and 2 and pre-dose 1 hour 24 hours and Days 3 7 and 14 after the dose are administered at Week 3 An overnight stay in the hospital is recommended for the first 24 hours At Weeks 0 1 2 and 3 virology testing including HIV-1 RNA is performed with each infusion of CD4-IgG Follow-up monitoring of patients is done once a month for 4 months for patients in Cohort II
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10699 | REGISTRY | None | None |
| ACTG 351 | Registry Identifier | DAIDS ES Registry Number | None |