Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001029
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease CD4 50mm3 With a Prior History of Nucleoside Therapy
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 compare the efficacy safety and tolerance and other clinical and immunologic effects of zidovudine AZT plus zalcitabine dideoxycytidine ddC AZT plus didanosine ddI and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cellsmm3
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV However one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV However one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs
Detailed Description:
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV However one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs
Patients are randomized to one of three treatment arms AZT plus ddI AZT plus ddC and AZT alone alternating monthly with ddI Half of the patients receiving AZT alternating monthly with ddI will start with AZT while the other half will start with ddI Treatment continues until death or termination of the study Patients are followed every 4 weeks The study will include a subset of patients for whom virologic pharmacokinetic and macroneurologic assessments will be made
Patients are randomized to one of three treatment arms AZT plus ddI AZT plus ddC and AZT alone alternating monthly with ddI Half of the patients receiving AZT alternating monthly with ddI will start with AZT while the other half will start with ddI Treatment continues until death or termination of the study Patients are followed every 4 weeks The study will include a subset of patients for whom virologic pharmacokinetic and macroneurologic assessments will be made
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 |
|---|---|---|---|
| 11168 | REGISTRY | DAIDS ES Registry Number | None |