Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001025
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
Evaluation of Patients Who Have Not Had Success With Zidovudine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance
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 determine the relationship of viral susceptibility to zidovudine AZT and baseline viral load as determined by plasma viremia and quantitative endpoint dilution To determine the relationship between viral load and susceptibility during different antiretroviral therapy strategies To correlate measures of viral load and short term clinical and laboratory markers such as weight CD4 count p24 antigenemia and beta2 microglobulin on the different therapy arms
High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year To elucidate the clinical significance of in vitro AZT resistance it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors
High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year To elucidate the clinical significance of in vitro AZT resistance it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors
Detailed Description:
High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year To elucidate the clinical significance of in vitro AZT resistance it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors
One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1 continue with AZT 2 switch to treatment with didanosine at 1 of 2 doses or 3 receive both AZT and ddI Treatment is given for 16 weeks with a possible extension to 32 weeks Patients are followed at weeks 2 4 8 12 and 16 For analysis purposes only patients are stratified according to degree of susceptibility of HIV isolates to AZT
One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1 continue with AZT 2 switch to treatment with didanosine at 1 of 2 doses or 3 receive both AZT and ddI Treatment is given for 16 weeks with a possible extension to 32 weeks Patients are followed at weeks 2 4 8 12 and 16 For analysis purposes only patients are stratified according to degree of susceptibility of HIV isolates to AZT
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 |
|---|---|---|---|
| 11170 | REGISTRY | DAIDS ES Registry Number | None |