Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001045
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Double-Blinded Randomized Trial Comparing Zidovudine AZT Versus AZT Plus Didanosine ddI Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in SerumPlasma Viral RNA
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 validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine AZT To determine whether alternative regimens of antiretroviral agents alter the course of viral burden as measured in the peripheral blood and CD4 changes in patients with HIV infection To obtain further data on the safety and immunologic and virologic response to AZTdidanosinenevirapine
Of the HIV-1 mutations reported to be associated with zidovudine resistance the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility When this mutation appears a change in drugs may prevent further immunologic and virologic deterioration
Of the HIV-1 mutations reported to be associated with zidovudine resistance the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility When this mutation appears a change in drugs may prevent further immunologic and virologic deterioration
Detailed Description:
Of the HIV-1 mutations reported to be associated with zidovudine resistance the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility When this mutation appears a change in drugs may prevent further immunologic and virologic deterioration
Initially all patients receive AZT alone After detection of a 215 mutation in plasma RNA patients are randomized to one of three treatment arms AZT alone AZT plus ddI or AZTddI plus nevirapine Patients are followed every 8 weeks and receive treatment for up to 4 years
AS PER AMENDMENT 5996 All AZT monotherapy options have been eliminated Patients will be randomized to either Arm II or Arm III regardless of their codon 215 status All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment
Initially all patients receive AZT alone After detection of a 215 mutation in plasma RNA patients are randomized to one of three treatment arms AZT alone AZT plus ddI or AZTddI plus nevirapine Patients are followed every 8 weeks and receive treatment for up to 4 years
AS PER AMENDMENT 5996 All AZT monotherapy options have been eliminated Patients will be randomized to either Arm II or Arm III regardless of their codon 215 status All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment
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 |
|---|---|---|---|
| 11221 | REGISTRY | DAIDS ES Registry Number | None |