Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000978
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
1999-11-02
Brief Title:
A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Randomized Dose-Finding Multicenter Trial of Dideoxycytidine ddC Administered Concurrently With Zidovudine AZT in the Treatment of AIDS or Advanced ARC
Status:
COMPLETED
Status Verified Date:
1992-08
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 safety tolerability and activity of zidovudine AZT and zalcitabine dideoxycytidine ddC and the bloodstream levels of these drugs in patients with AIDS or advanced AIDS-related complex ARC
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects In addition AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together If the doses can be reduced then toxicity associated with long-term use of one drug may be reduced Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy Although the clinical significance of this finding is not clear it would indicate that these combination studies are all the more important HIV strains with decreased sensitivity to AZT are still sensitive to ddC
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects In addition AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together If the doses can be reduced then toxicity associated with long-term use of one drug may be reduced Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy Although the clinical significance of this finding is not clear it would indicate that these combination studies are all the more important HIV strains with decreased sensitivity to AZT are still sensitive to ddC
Detailed Description:
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects In addition AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together If the doses can be reduced then toxicity associated with long-term use of one drug may be reduced Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy Although the clinical significance of this finding is not clear it would indicate that these combination studies are all the more important HIV strains with decreased sensitivity to AZT are still sensitive to ddC
Patients are randomly assigned to one of six treatment groups of various dose combinations of AZT and ddC Patients are evaluated every week for the first 10 weeks and biweekly thereafter
Patients are randomly assigned to one of six treatment groups of various dose combinations of AZT and ddC Patients are evaluated every week for the first 10 weeks and biweekly thereafter
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 |
|---|---|---|---|
| Protocol N3447 | None | None | None |