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| Descriptive Information Fields | |
| Brief Title † | A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy |
| Official Title † | A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy |
| Brief Summary | To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment. To describe the safety, tolerance, and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe survival of people with AIDS and CMV retinitis. |
| Detailed Description | Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral ganciclovir. |
| Study Phase | |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Cytomegalovirus Retinitis HIV Infections |
| Intervention † | Drug: Ganciclovir |
| MEDLINE PMIDs | 9110064 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 225 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
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| Gender | Both |
| Ages | 13 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States, Canada |
| Administrative Information Fields | |
| NCT ID † | NCT00002247 |
| Organization ID | 059C |
| Secondary IDs †† | ICM 1774 |
| Study Sponsor † | Hoffmann-La Roche |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | March 1993 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |