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NCT00001061 · ClinicalTrials.gov registry record · Phase 2
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 167
- Enrollment target
NCT00001061 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 167 participants.
The verdict
NCT00001061, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 167 participants
- Enrollment target
Study 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.
Interventions
- DRUG Foscarnet sodium
- DRUG Ganciclovir
- DRUG Sevirumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Est. Completion | 1998-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001061
The ClinicalTrials.gov registry entry for NCT00001061 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Foscarnet sodium is the first listed.
NCT00001061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001061 about?
NCT00001061 is a clinical study titled "Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS". 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 mar...
What is the current status of trial NCT00001061?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 167 participants. Estimated completion is 1998-03.
What interventions are being tested in trial NCT00001061?
The interventions under investigation include: Foscarnet sodium (DRUG), Ganciclovir (DRUG), Sevirumab (DRUG).
Who is sponsoring clinical trial NCT00001061?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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