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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 167 participants
Est. Completion 1998-03
Phase Phase 2

What the finished NCT00001061 record still lists

NCT00001061 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).

The record links to 0 conditions, and to 3 interventions - of which Foscarnet sodium is the first listed.

NCT00001061 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00001061's enrollment target sits among peer trials

167 406th of 2000 higher than 1,595 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001061, the US trial registry maintained by the National Library of Medicine. NCT00001061 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.