Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001066
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
1999-11-02
Brief Title:
A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 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 Randomized Comparative Study of Combined Zidovudine-Lamivudine 3TC vs the Better of ddI Monotherapy vs Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children
Status:
COMPLETED
Status Verified Date:
2011-03
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 compare the efficacy of lamivudine 3TC and zidovudine AZT in combination versus the better of didanosine ddI monotherapy or ddIAZT combination in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy To evaluate the safety and tolerance of 3TCAZT in this patient population To determine other measures of diseases in response to the study regimens
Currently none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use However previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells Additionally 3TC has demonstrated a favorable safety profile
Currently none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use However previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells Additionally 3TC has demonstrated a favorable safety profile
Detailed Description:
Currently none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use However previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells Additionally 3TC has demonstrated a favorable safety profile
Patients are randomized to receive oral 3TCAZT ddIAZT or ddI alone for at least 24 months PER AMENDMENT 42996 NOTE Randomization to ZDVddI arm was terminated in Spring of 1996 based upon the results of ACTG 152 Patients on that arm will continue on blinded study drug and will be followed until the end of the study
Patients are randomized to receive oral 3TCAZT ddIAZT or ddI alone for at least 24 months PER AMENDMENT 42996 NOTE Randomization to ZDVddI arm was terminated in Spring of 1996 based upon the results of ACTG 152 Patients on that arm will continue on blinded study drug and will be followed until the end of the study
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?: