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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

This study has been completed.
Study NCT00002247.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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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:

  • Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
  • ddI.
  • ddC.

Patients must have:

  • Confirmed HIV infection or diagnosis of AIDS.
  • CMV retinitis of no more than 4 months duration.
  • Stable retinitis.
  • Understanding of the nature of the study, agree to its provisions, and sign informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease.
  • Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
  • Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment).
  • Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol.

Concurrent Medication:

Excluded:

  • Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
  • Antimetabolites.
  • Alkylating agents.
  • Selected nucleoside analogs.
  • Selected cytokines.

Patients with the following prior conditions are excluded:

  • Diagnosis of CMV retinitis more than 4 months prior to study entry.
  • More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted).

Prior Medication:

Excluded:

  • More than two induction treatment regimens with IV ganciclovir.
  • Prior oral ganciclovir (in Groups A, B, and C only).
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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