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)
Enter a location and click search to find clinical trials sorted by distance.
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