Status:

COMPLETED

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Cytomegalovirus Retinitis

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE1

Brief Summary

To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS patients. A systemic...

Detailed Description

A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has be...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Erythropoietin, G-CSF, or GM-CSF.
  • Antiretrovirals.

Patients must have:

  • HIV infection.
  • Evaluable CMV retinitis with photographable lesions.
  • Life expectancy of at least 6 months.
  • No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression.
  • Corneal, lens, or vitreous opacification precluding funduscopic exam.
  • Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion.
  • Inability to obtain temporary IV access.
  • Requirement for permanent catheters for IV ganciclovir administration.
  • Uncontrolled diarrhea or nausea preventing ingestion of medicine.
  • Known hypersensitivity to IV or oral ganciclovir.

Concurrent Medication:

Excluded:

  • Immunomodulators.
  • Biologic response modifiers.
  • Interferon.
  • Related investigational agents.
  • CMV prophylaxis.
  • Systemic acyclovir.
  • Any nephrotoxic agent.
  • Any concomitant therapy that would prohibit use of ganciclovir.

Prior Medication:

Excluded:

  • Prior treatment for CMV retinitis.
  • More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks prior to study entry.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

January 1 1998

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00001062

End Date

January 1 1998

Last Update

November 4 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

UCLA CARE Center CRS

Los Angeles, California, United States, 90095

2

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

3

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States, 21287

4

Cornell University A2201

New York, New York, United States, 10021

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes | DecenTrialz