A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections
Intervention: Zidovudine (Drug); Ganciclovir (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hoffmann-La Roche
Summary
To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly
diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate
the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the
safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT).
(Patients utilizing treatment with other anti-retroviral drugs will be considered for study
entry on a case by case basis.) To determine survival in this group of patients with AIDS
and CMV retinitis.
Clinical Details
Official title: A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
- Topical acyclovir.
- Selected cytokines.
- Allowed after the first 4 weeks of ganciclovir:
- Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated
ganciclovir without grade 3/4 hematological toxicity.
- Other anti-retrovirals after consultation with the Syntex study monitor.
Patients must have the following:
- AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.
- An understanding of the nature of the study, agreement to its provisions, and
willingness to sign the informed consent approved by the appropriate institutions
review board, and Syntex.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Have only peripheral CMV retinitis (defined as a lesion outside the major temporal
vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000
microns from the fovea).
- Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic
retinal assessment.
- Ocular conditions requiring immediate surgical correction (eg:
- retinal tear or detachment).
- Demonstrated hypersensitivity to acyclovir or ganciclovir.
- Dementia, decreased mentation or other encephalopathic signs and symptoms which would
interfere with the ability of the patient to comply with the protocol.
Concurrent Medication:
Excluded:
- Antimetabolites.
- Alkylating agents.
- Nucleoside analogs (excluding selected anti-retroviral agents).
- Imipenem-cilastatin.
- Interferons.
- Selected cytokines.
- Acyclovir (except topical acyclovir).
Patients with the following are excluded:
- Have only peripheral CMV retinitis (defined as a lesion outside the major temporal
vascular arcades, greater than 1500 microns from the optic disk or greater than 3000
microns from the fovea).
- Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.
Prior Medication:
Excluded within 1 month of study entry:
- Previous treatment with anti-cytomegalovirus therapy (e. g., ganciclovir, foscarnet or
CMV hyperimmune globulin).
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Southern Alberta HIV Clinic / Foothills Hosp, Calgary, Alberta, Canada
Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California 94609, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States
Dr Winkler Weinberg, Roswell, Georgia 30076, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States
Dr Alfred F Burnside Jr, Columbia, South Carolina 29204, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Additional Information
Last updated: June 23, 2005
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