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NCT00001611 · ClinicalTrials.gov registry record

Immune Activity Against CVM Retinitis

A clinical trial, sponsored by National Eye Institute (NEI).

Completed
Registry status
15
Enrollment target

NCT00001611 is a clinical trial that has completed, run by National Eye Institute (NEI). The registered enrollment target is 15 participants.

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The verdict

NCT00001611 has completed, sponsored by National Eye Institute (NEI).

COMPLETED
Registry status
15 participants
Enrollment target

Study Summary

This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral infection of the eye-can safely be stopped in HIV-infected patients whose immune function has improved from anti-HIV therapy. Medicines taken to fight CMV infection (ganciclovir, foscarnet, and cidofovir) can cause serious side effects, such as low blood counts and kidney damage. Stopping these medications may, therefore, be beneficial. Patients with HIV infection who develop CVM retinitis usually have very low levels of infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of blood. New anti-HIV medications have been able to raise CD4 levels and improve immune function in many patients. This study will see if patients with CD4 levels above 150 cells per microliter can fight CVM retinitis without additional anti-CVM drugs. HIV-infected patients with CVM retinitis will have a physical examination and complete eye examination. These tests will be repeated after 2 weeks. If there is no evidence that the CMV infection has progressed, and if it is in a location that is not immediately sight-threatening, anti-CMV medications will be stopped. Patients will be examined every 2 weeks for 3 months and then every 3 weeks for the next 3 months. Patients whose CD4 count has remained above 100 after 6 months will continue to be followed every 4 weeks until the CVM infection becomes active again. At that time, anti-CVM medicines will be re-started. Patients will also have blood and urine samples taken to test for levels of HIV and CMV in the blood and urine, and will be interviewed about their vision and how it affects daily activities.

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 1997-02
Est. Completion 2004-04

Sponsor

National Eye Institute (NEI)

221 total trials

What the Registry Record Tells You About NCT00001611

The ClinicalTrials.gov registry entry for NCT00001611 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00001611 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00001611 about?

NCT00001611 is a clinical study titled "Immune Activity Against CVM Retinitis". This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral infection of the eye-can safely be stopped in HIV-infected patients whose immune function has improved from anti-HIV therapy. Medicines taken to fight CMV infection (ganciclovir, foscarnet, and cidofovir) can ...

What is the current status of trial NCT00001611?

This trial is currently completed. The enrollment target is 15 participants. The study started on 1997-02. Estimated completion is 2004-04.

Who is sponsoring clinical trial NCT00001611?

This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.

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