|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| 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 | |
| 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 | |
| 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
| ClinicalTrials.gov Identifier: | NCT00002034 History of Changes |
| Other Study ID Numbers: | 029F, ICM 1692 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis AIDS-Related Opportunistic Infections Ganciclovir Drug Interactions |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Zidovudine |
|
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Retinal Diseases Eye Diseases |
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Zidovudine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |