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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Retinitis AIDS-Related Opportunistic Infections Ganciclovir Drug Interactions |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Zidovudine |
Antimetabolites Opportunistic Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Retinitis Zidovudine Cytomegalovirus Reverse Transcriptase Inhibitors Anti-Retroviral Agents AIDS-Related Opportunistic Infections Cytomegalic Inclusion Disease Cytomegalovirus Infections Retroviridae Infections Retinal Diseases |
Anti-HIV Agents Eye Diseases Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Ganciclovir Antiviral Agents Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases DNA Virus Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Retinitis Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors Retinal Diseases |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Eye Infections, Viral Eye Diseases Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Enzyme Inhibitors Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |