Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001061
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Double-Masked Randomized Placebo-Controlled Evaluation of Standard Therapy vs Standard Therapy Combined With Human Monoclonal Anti-Cytomegalovirus Antibody MSL 109 in the Therapy of AIDS Patients With Cytomegalovirus CMV Retinitis
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 effect of MSL 109 human monoclonal anti-cytomegalovirus CMV antibody on time to progression of CMV retinitis To determine the safety and pharmacokinetic profile of MS 109 To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing Alternatively MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing Alternatively MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients
Detailed Description:
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing Alternatively MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients
Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs AS PER AMENDMENT 112996 Enrollment onto the current study has been discontinued To study the enhancement of humoral immunity a high-dose cohort has been added Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before Randomization is weighted 21 in favor of high-dose MSL 109 Interim analyses will be performed to provide for early discontinuation as indicated Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached
Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs AS PER AMENDMENT 112996 Enrollment onto the current study has been discontinued To study the enhancement of humoral immunity a high-dose cohort has been added Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before Randomization is weighted 21 in favor of high-dose MSL 109 Interim analyses will be performed to provide for early discontinuation as indicated Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11242 | REGISTRY | DAIDS ES Registry Number | None |