Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002436
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Lamivudine 3TCDideoxycytidine ddC Double-Blind Multicenter Trial With Open-Label AZT to Evaluate the Safety and Efficacy of Low Dose 3TC Administered Concurrently With AZT Versus High Dose 3TC Administered Concurrently With AZT Versus ddC Administered Concurrently With AZT in the Treatment of HIV-1 Infected AZT-Experienced 24 Weeks Patients With CD4 Counts of 100-300 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1994-05
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 safety and efficacy of low and high doses of lamivudine 3TC in combination with zidovudine AZT and zalcitabine dideoxycytidine ddC in combination with AZT
PER 022795 AMENDMENT To evaluate the efficacy and safety of both blinded and open-label combination therapy
PER 022795 AMENDMENT To evaluate the efficacy and safety of both blinded and open-label combination therapy
Detailed Description:
Patients are randomized to one of three treatment arms low-dose 3TC plus AZT high-dose 3TC plus AZT or ddC plus AZT Treatment continues for 32 weeks with possible extension to 52 weeks
PER 022795 AMENDMENT Patients may continue therapy on AZT and low-dose 3TC on an open-label basis Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates
PER 022795 AMENDMENT Patients may continue therapy on AZT and low-dose 3TC on an open-label basis Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates
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 |
|---|---|---|---|
| NUCA 3002 | None | None | None |