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.

Condition	Treatment or Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir

Further Study Details: 

Expected Total Enrollment:  225

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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).

California
      San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
      Davies Med Ctr / c/o HIV Institute, San Francisco,  California,  94114,  United States
      UCSD Med Ctr / Pediatrics, San Diego,  California,  92103,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94704,  United States
      Mount Zion Med Ctr, San Francisco,  California,  94115,  United States
      Dr David Busch, San Francisco,  California,  94118,  United States
      AIDS Clinical Research Ctr / UCLA Med Ctr, Los Angeles,  California,  900951793,  United States
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
Florida
      Miami Veterans Administration Med Ctr, Miami,  Florida,  33125,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Hawaii
      Margo Heath - Chiozzi, Honolulu,  Hawaii,  96816,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll, Chicago,  Illinois,  60612,  United States
Massachusetts
      Beth Israel Hosp, Boston,  Massachusetts,  02215,  United States
New York
      Dr Dorothy Friedberg, New York,  New York,  10016,  United States
      Cornell Univ Med College, New York,  New York,  10021,  United States
Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Univ TX Galveston Med Branch, Galveston,  Texas,  77550,  United States
      Oak Lawn Physicians Group, Dallas,  Texas,  75219,  United States
Washington
      Univ of Washington / Pacific Med Ctr, Seattle,  Washington,  98144,  United States
Canada, British Columbia
      Saint Paul's Hosp, Vancouver,  British Columbia,  Canada

Study ID Numbers:  059C; ICM 1774
Record last reviewed:  March 1993
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002247
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08