Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002437
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus CMV of the Eyes in Patients With AIDS
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IIIII Study of the Safety and Efficacy of 1-S-3-Hydroxy-2-PhosphonylmethoxypropylCytosine Dihydrate Cidofovir HPMPC for the Treatment of Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Status:
COMPLETED
Status Verified Date:
1994-11
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 whether cidofovir HPMPC therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus CMV retinitis in AIDS patients To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine blood andor semen To evaluate the impact of HPMPC therapy on visual acuity
Detailed Description:
Patients are randomized to one of two treatment arms Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks induction and then every other week maintenance with oral probenecid and IV hydration Group B receives no treatment until the time of retinitis progression deferred treatment at which time they receive the same regimen as Group A provided retinitis progression is not immediately sight-threatening
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 |
|---|---|---|---|
| GS-93-106 | None | None | None |