Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000679
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
Ro 24-2027 A Randomized Double-Blind Comparative Study of Dideoxycytidine ddC Versus Zidovudine AZT in Patients With AIDS or Advanced ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Ro 24-2027 A Randomized Double-Blind Comparative Study of Dideoxycytidine ddC Versus Zidovudine AZT in Patients With AIDS or Advanced ARC
Status:
COMPLETED
Status Verified Date:
1994-12
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 show that zalcitabine dideoxycytidine ddC is at least as effective as zidovudine AZT in the treatment of AIDS or advanced AIDS related complex ARC and also that ddC shows a different safety profile than AZT
In clinical studies ddC shows antiviral activity Because of the antiviral activity and because of the low incidence of mild reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy a long-term Phase IIIII study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted
In clinical studies ddC shows antiviral activity Because of the antiviral activity and because of the low incidence of mild reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy a long-term Phase IIIII study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted
Detailed Description:
In clinical studies ddC shows antiviral activity Because of the antiviral activity and because of the low incidence of mild reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy a long-term Phase IIIII study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted
After screening physical examination and laboratory tests within 14 days of entry patients are randomized to one of two treatment groups They receive either ddC plus an AZT placebo or AZT plus a ddC placebo Because it is a blinded study patients do not know which group they are in Patients are evaluated weekly for the first 10 weeks and then biweekly thereafter
After screening physical examination and laboratory tests within 14 days of entry patients are randomized to one of two treatment groups They receive either ddC plus an AZT placebo or AZT plus a ddC placebo Because it is a blinded study patients do not know which group they are in Patients are evaluated weekly for the first 10 weeks and then 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 |
|---|---|---|---|
| Study Number 3-27 | None | None | None |
| Protocol Number N3300A | None | None | None |
| FDA 31A | None | None | None |