Status:
COMPLETED
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
3+ years
Phase:
PHASE3
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 ...
Detailed Description
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 patien...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000698
End Date
August 1 2007
Last Update
September 30 2008
Active Locations (1)
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1
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, United States, 20892