Completed
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2008-09-30
N/A
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
To determine the safety and effectiveness of intravenous ganciclovir (also known as DHPG) in the treatment of sight-threatening cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of CMV retinitis.
CONDITIONS
Official Title
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
- Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia.
- Topical ophthalmics.
- Topical acyclovir.
Concurrent Treatment:
Allowed:
- Hemodialysis for patients with renal impairment.
Patients must have:
- Diagnosis of AIDS and immediately sight-threatening cytomegalovirus retinitis.
Prior Medication:
Allowed:
- Zidovudine.
- Prior therapy for retinitis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Non-immediately sight-threatening cytomegalovirus retinitis.
Concurrent Medication:
Excluded:
- Systemic investigational agents such as antimetabolites, alkylating agents, nucleoside analogs, acyclovir sodium (Zovirax).
- Interferon.
- Cytokines.
- Foscarnet (non-nucleoside pyrophosphate analog).
- Ganciclovir may be withheld for up to 21 days for an acute course with an investigational or toxic therapy or oral / IV acyclovir.
Patients with the following are excluded:
- Non-immediately sight-threatening cytomegalovirus retinitis.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, United States, 20892
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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