Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000625
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Randomized Double-Blind Phase IIIII Trial of Monotherapy vs Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500mm3
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 Phase IIIII Trial of Monotherapy vs Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500mm3
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 efficacy and safety of zidovudine AZT versus didanosine ddI AZT plus ddI and AZT plus zalcitabine ddC in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cellsmm3
Detailed Description:
Patients are randomized to receive AZT alone AZT and ddI AZT and ddC or ddI alone for at least 2 years Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm
PER AMENDMENT 4595 Study treatment will be available until 103195 at the latest for patients still taking study medications on 43095 so that follow-up trials may be completed and approved
PER AMENDMENT 4595 Study treatment will be available until 103195 at the latest for patients still taking study medications on 43095 so that follow-up trials may be completed and approved
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 |
|---|---|---|---|
| 11150 | REGISTRY | DAIDS ES Registry Number | None |