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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002034 |
Purpose
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 |
|---|---|
|
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 |
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| 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 Anti-Infective Agents Communicable Diseases 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 |