Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000781
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Randomized Double-Blind Four-Arm Study Comparing Combination Nucleoside Alternating Nucleoside and Triple-Drug Therapy for the Treatment of Advanced HIV Disease CD4 50mm3
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 Four-Arm Study Comparing Combination Nucleoside Alternating Nucleoside and Triple-Drug Therapy for the Treatment of Advanced HIV Disease CD4 50mm3
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 relative clinical efficacy of zidovudine AZT plus didanosine ddI AZT plus zalcitabine ddC AZT alternating monthly with ddI and AZTddI plus nevirapine in HIV-infected patients with advanced disease
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity
Detailed Description:
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity
Patients are randomized to receive either AZTddC AZTddI AZT alternating monthly with ddI or AZTddInevirapine Patients are evaluated at week 0 and every 4 weeks thereafter for 2 years Pharmacologic virologic and macroneurologic substudies will be conducted Patients who are already enrolled on protocol ACTG 193 will be given the option of continuing on their originally assigned ACTG 193 therapy for an additional 6 months or undergoing re-randomization to one of the four treatment arms on ACTG 193A
Patients are randomized to receive either AZTddC AZTddI AZT alternating monthly with ddI or AZTddInevirapine Patients are evaluated at week 0 and every 4 weeks thereafter for 2 years Pharmacologic virologic and macroneurologic substudies will be conducted Patients who are already enrolled on protocol ACTG 193 will be given the option of continuing on their originally assigned ACTG 193 therapy for an additional 6 months or undergoing re-randomization to one of the four treatment arms on ACTG 193A
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 |
|---|---|---|---|
| 11169 | REGISTRY | DAIDS ES Registry Number | None |