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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002034 |
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.
Condition | Intervention |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Zidovudine Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
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 |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 1 month of study entry:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Stanford at Kaiser / Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
Summitt Med Ctr / San Francisco Gen Hosp | |
Oakland, California, United States, 94609 | |
United States, Florida | |
Miami Veterans Administration Med Ctr | |
Miami, Florida, United States, 33125 | |
United States, Georgia | |
Dr Winkler Weinberg | |
Roswell, Georgia, United States, 30076 | |
United States, New York | |
SUNY / Health Sciences Ctr at Stony Brook | |
Stony Brook, New York, United States, 117948153 | |
United States, South Carolina | |
Dr Alfred F Burnside Jr | |
Columbia, South Carolina, United States, 29204 | |
United States, Texas | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 77550 | |
Canada, Alberta | |
Southern Alberta HIV Clinic / Foothills Hosp | |
Calgary, Alberta, Canada |
Study ID Numbers: | 029F, ICM 1692 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002034 |
Health Authority: | United States: Food and Drug Administration |
Retinitis AIDS-Related Opportunistic Infections Ganciclovir Drug Interactions |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Zidovudine |
Opportunistic Infections Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Zidovudine Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes |
Herpesviridae Infections Cytomegalovirus retinitis Virus Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Eye Infections, Viral Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |