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

Completed · Phase 1

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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 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 been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter.

Key facts

Study ID

NCT00001062

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

25

Expected to finish

1998-01-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Cornell University A2201 — New York, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.