A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1992
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.
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
| Estimated Enrollment:
|Ages Eligible for Study:
||13 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
- Alkylating agents.
- Nucleoside analogs (excluding selected anti-retroviral agents).
- 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.
Excluded within 1 month of study entry:
- Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002034
|Univ of Alabama at Birmingham
|Birmingham, Alabama, United States, 35294 |
|Summitt Med Ctr / San Francisco Gen Hosp
|Oakland, California, United States, 94609 |
|Stanford at Kaiser / Kaiser Permanente Med Ctr
|San Francisco, California, United States, 94115 |
|Miami Veterans Administration Med Ctr
|Miami, Florida, United States, 33125 |
|Dr Winkler Weinberg
|Roswell, Georgia, United States, 30076 |
|SUNY / Health Sciences Ctr at Stony Brook
|Stony Brook, New York, United States, 117948153 |
|Dr Alfred F Burnside Jr
|Columbia, South Carolina, United States, 29204 |
|Univ TX Galveston Med Branch
|Galveston, Texas, United States, 77550 |
|Southern Alberta HIV Clinic / Foothills Hosp
|Calgary, Alberta, Canada |
No publications provided
History of Changes
|Other Study ID Numbers:
||029F, ICM 1692
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 08, 2015
DNA Virus Infections
Eye Infections, Viral
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors