Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000984
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 rCD4 in Infants and Children Infected With or at Risk for HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 rCD4 in Infants and Children Infected With or at Risk for HIV Infection
Status:
COMPLETED
Status Verified Date:
1996-10
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:
AMENDED As of 101990 only Children 0 to 3 months are being enrolled Original design To determine whether the experimental drug recombinant CD4 rCD4 which is produced through genetic engineering technology is safe and well-tolerated in children infected with or at risk for HIV infection
rCD4 may be an effective treatment for HIV infection based on its ability to block infection of human cells by HIV in laboratory tests However the activity of rCD4 still needs to be confirmed in clinical trials It is hoped that these tests will show that rCD4 is both safe and effective in treating children who are infected with or who are at risk for infection with HIV
rCD4 may be an effective treatment for HIV infection based on its ability to block infection of human cells by HIV in laboratory tests However the activity of rCD4 still needs to be confirmed in clinical trials It is hoped that these tests will show that rCD4 is both safe and effective in treating children who are infected with or who are at risk for infection with HIV
Detailed Description:
rCD4 may be an effective treatment for HIV infection based on its ability to block infection of human cells by HIV in laboratory tests However the activity of rCD4 still needs to be confirmed in clinical trials It is hoped that these tests will show that rCD4 is both safe and effective in treating children who are infected with or who are at risk for infection with HIV
Children have preliminary testing and evaluation to determine eligibility and health The dosage schedule varies with the dose During the course of the study children are monitored for safety through physical exams and blood tests They have blood withdrawn to study the response to rCD4 and measure the activity of rCD4 in the body Children may receive immunization of DPT diphtheria pertussis tetanus or DT and a polio vaccine to measure their antibody response If the rCD4 is beneficial children may continue treatment The study is conducted in four parts
Part A Children 13 to 18 years old
Part B Children 3 months to less than 13 years old
Part C Full-term infants over 3 months old
Part D Preterm infants less than 3 months old Parts C and D are not started until parts A and B have been completed
Children have preliminary testing and evaluation to determine eligibility and health The dosage schedule varies with the dose During the course of the study children are monitored for safety through physical exams and blood tests They have blood withdrawn to study the response to rCD4 and measure the activity of rCD4 in the body Children may receive immunization of DPT diphtheria pertussis tetanus or DT and a polio vaccine to measure their antibody response If the rCD4 is beneficial children may continue treatment The study is conducted in four parts
Part A Children 13 to 18 years old
Part B Children 3 months to less than 13 years old
Part C Full-term infants over 3 months old
Part D Preterm infants less than 3 months old Parts C and D are not started until parts A and B have been completed
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 |
|---|---|---|---|
| CO102G | None | None | None |