To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.

Condition	Treatment or Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir

Further Study Details: 

Expected Total Enrollment:  450

Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.

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

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Topical drugs and ophthalmics. Patients must have:
• AIDS.
• Unilateral CMV retinitis.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
• Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
• Acute retinal necrosis or any other intraocular condition that might preclude study completion.
• Ocular condition requiring immediate surgery.
• Unable to have long-term IV catheter placement. Concurrent Medication: Excluded:
• Vidarabine.
• Amantadine hydrochloride.
• Cytarabine.
• FIAC or FIAU.
• Idoxuridine.
• Ribavirin.
• Valacyclovir.
• Foscarnet.
• CMV hyperimmune globulin.
• Soluble CD4.
• Trichosanthin.
• Imipenem-cilastatin.
• Isoprinosine.
• Levamisole.
• Interferon.
• Other investigational drugs. Patients with the following prior conditions are excluded:
• History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
• History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded:
• Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
• Prior intravitreal ganciclovir implant.
• More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
• Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).

California
      Pacific Horizons Med Group, San Francisco,  California,  94115,  United States
      Dr Robert Avery, Santa Barbara,  California,  93103,  United States
      Dr Neil Brourman, Beverly Hills,  California,  90211,  United States
      Estelle Doheny Eye Clinic, Los Angeles,  California,  90033,  United States
      Harbor - UCLA Med Ctr, Torrance,  California,  90509,  United States
      Santa Clara Valley Med Ctr, San Jose,  California,  95128,  United States
      Dr Robert T Wendel, Sacramento,  California,  95819,  United States
      Kaiser Hosp, San Francisco,  California,  94115,  United States
      UCI College of Medicine, Irvine,  California,  92715,  United States
District of Columbia
      Dr Alan Palestine, Washington,  District of Columbia,  20036,  United States
Florida
      Bascom Palmer, Miami,  Florida,  33136,  United States
      Dr Michael Stewart, Jacksonville,  Florida,  32204,  United States
Georgia
      Emory Eye Clinic, Atlanta,  Georgia,  30322,  United States
Illinois
      Dr David Weinberg, Chicago,  Illinois,  60611,  United States
Kentucky
      Univ of Kentucky Med Ctr, Lexington,  Kentucky,  40536,  United States
Massachusetts
      New England Med Ctr / Tufts Univ, Boston,  Massachusetts,  02111,  United States
New York
      Dr Dorothy Friedberg, New York,  New York,  10016,  United States
      New York Hosp, New York,  New York,  10021,  United States
      Saint Clare's Prof Office, New York,  New York,  10019,  United States
      Vitreo - Retinal Consultants, New York,  New York,  10028,  United States
Texas
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
Washington
      Univ of Washington Med Ctr, Seattle,  Washington,  98195,  United States

Study ID Numbers:  037B; GANS2304
Record last reviewed:  July 1997
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002134
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08