Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000682
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Randomized Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
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 evaluate the efficacy of AZT versus ddC in terms of survival antiviral effects neurological status and health status in patients post Pneumocystis carinii pneumonia PCP who received long-term AZT therapy in ACTG protocol 002 While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS during the second year of administration of AZT an acceleration in mortality has been observed The reasons for this are not known at this time The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients
Detailed Description:
While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS during the second year of administration of AZT an acceleration in mortality has been observed The reasons for this are not known at this time The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients
Following tests to evaluate their health patients are chosen at random to receive either AZT or ddC AZT is given by mouth at the patients current dose ddC is given by mouth every 8 hours Treatment continues for up to 12 months Patients are required to visit the clinic every 2 weeks up to week 12 and then once a month Blood samples are taken to monitor the safety and effectiveness of treatment
Following tests to evaluate their health patients are chosen at random to receive either AZT or ddC AZT is given by mouth at the patients current dose ddC is given by mouth every 8 hours Treatment continues for up to 12 months Patients are required to visit the clinic every 2 weeks up to week 12 and then once a month Blood samples are taken to monitor the safety and effectiveness of treatment
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 |
|---|---|---|---|
| 11087 | REGISTRY | DAIDS ES Registry Number | None |