Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000865
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and 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 I Safety and Pharmacokinetic Study of 1592U89 Alone and In Combination With Other Antiretroviral Agents in Infants and Children With HIV Infection
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:
To assess the steady state pharmacokinetic features tolerance and safety of orally administered 1592U89 given alone or in combination with other antiretroviral medications in HIV infected infants and children To establish doses of 1592U89 appropriate for future pediatric Phase IIIII clinical trials
On the basis of the preclinical and clinical studies 1592U89 appears to be a promising agent for treatment of HIV infection in children either as an alternative to currently employed agents or in combination therapy regimens A liquid formulation of the drug is available thus concurrent development of 1592U89 for children and adults is possible
On the basis of the preclinical and clinical studies 1592U89 appears to be a promising agent for treatment of HIV infection in children either as an alternative to currently employed agents or in combination therapy regimens A liquid formulation of the drug is available thus concurrent development of 1592U89 for children and adults is possible
Detailed Description:
On the basis of the preclinical and clinical studies 1592U89 appears to be a promising agent for treatment of HIV infection in children either as an alternative to currently employed agents or in combination therapy regimens A liquid formulation of the drug is available thus concurrent development of 1592U89 for children and adults is possible
In part 1 patients will receive 1592U89 monotherapy for 12 weeks Patients will be assigned initially to a low dose of 1592U89 Dose A Those patients who tolerate the drug for at least six weeks without a toxicity of grade 3 or above attributable to study drug will have their 1592U89 dose increased Dose B If none of those patients experience a life threatening event attributable to study drug subsequent enrollees will be assigned initially to Dose B In part 2 each participant will be assigned randomly 1111 within their age and Part 1 regimen stratum to one of the four agents Zidovudine ZDV Stavudine d4T Didanosine ddI or Lamivudine 3TC in combination with 1592U89
In part 1 patients will receive 1592U89 monotherapy for 12 weeks Patients will be assigned initially to a low dose of 1592U89 Dose A Those patients who tolerate the drug for at least six weeks without a toxicity of grade 3 or above attributable to study drug will have their 1592U89 dose increased Dose B If none of those patients experience a life threatening event attributable to study drug subsequent enrollees will be assigned initially to Dose B In part 2 each participant will be assigned randomly 1111 within their age and Part 1 regimen stratum to one of the four agents Zidovudine ZDV Stavudine d4T Didanosine ddI or Lamivudine 3TC in combination with 1592U89
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 |
|---|---|---|---|
| 11302 | REGISTRY | DAIDS ES | None |