Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001267
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 23-Dideoxyinosine
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 23-Dideoxyinosine
Status:
COMPLETED
Status Verified Date:
1999-08
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:
Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities This study will involve therapy of patients with AIDS or ARC with two of these agents AZT and 2 3-dideoxyinosine ddI which have different toxicity profiles over a 2-year period of time The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs The study will be structured as a randomized pilot study
Detailed Description:
Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities This study will involve therapy of patients with AIDS or ARC with two of these agents AZT and 2 3-dideoxyinosine ddI which have different toxicity profiles over a 2-year period of time The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs The study will be structured as a randomized pilot study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91-C-0018 | None | None | None |