A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedSeptember 30, 2008
April 1, 1992
November 2, 1999
September 26, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, 20892, United States
Related Publications (1)
Feinberg J, Katz D, Mastre B, DeArmond B. Ganciclovir (GCV) in AIDS patients with immediately sight-threatening CMV retinitis (ISTCR): initial summary of "treatment IND" data. Int Conf AIDS. 1990 Jun 20-23;6(1):230 (abstract no ThB432)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Feinberg J
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
August 1, 2007
Last Updated
September 30, 2008
Record last verified: 1992-04