Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002373
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus CMV of the Eyes in HIV-Infected Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Trial to Evaluate the Tolerability Anti-CMV Activity and Pharmacokinetics of 1263W94 Following Multiple Oral Administration of Escalating Doses in HIV-Infected Patients With Asymptomatic CMV Shedding
Status:
COMPLETED
Status Verified Date:
1998-11
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 evaluate the safety and tolerability of multiple escalating doses of 1263W94 administered orally for 28 days in HIV infected patients with asymptomatic CMV shedding To obtain preliminary evidence of the in vivo anti CMV activity of different doses of 1263W94 in humans based on quantitative reduction of CMV load in semen and if possible in other biological fluids and to explore the dose response relationship in the anti-CMV activity of 1263W94
Detailed Description:
HIV seropositive men stratified based on CMV titer in semen at the Pre-Screen visit 30 days prior to entry Patients with a CMV titer 5000 PFUml and a positive result upon qualitative urine CMV culture may be eligible for entry into the main group and patients with a CMV titer 5000 PFUml may be eligible for entry into the satellite group Patients will on 1263W94 for 4 weeks Patients will be present for clinic visits on study days 1 7 14 21 and 28 They will return to the clinic for post treatment evaluations on study days 42 and 56
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 |
|---|---|---|---|
| CMAA1003 | None | None | None |