To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.

Condition	Treatment or Intervention
Cytomegalovirus Infections HIV Infections	Drug: Ganciclovir

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

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Topical or ophthalmic nucleoside analogs. Patients must have:
• Confirmation of HIV infection.
• Documented CMV infection.
• No past or present CMV disease (e.g., retinitis, colitis, esophagitis).
• Adequate visualization of the retina of both eyes by ophthalmologist.
• CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).

Exclusion Criteria

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

• Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).
• Inability to comply with protocol.

Concurrent Medication: Excluded:

• The following nucleoside analogs:
• IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.
• FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.
• Imipenem-cilastatin (Primaxin). Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir. Prior Medication: Excluded within the past 60 days: Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.

California
      San Francisco Veterans Administration Med Ctr, San Francisco,  California,  94121,  United States
      Davies Med Ctr / c/o HIV Institute, San Francisco,  California,  94114,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
      Mount Zion Med Ctr, San Francisco,  California,  94115,  United States
      UCSD, San Diego,  California,  92103,  United States
      Harbor - UCLA Med Ctr, Torrance,  California,  90502,  United States
      Kraus - Beer Med Group, Los Angeles,  California,  90028,  United States
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
Florida
      Community Research Initiative, Coral Gables,  Florida,  33146,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  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
      Kaplan Cancer Ctr / New York Univ Med Ctr, New York,  New York,  10016,  United States
      St Lukes - Roosevelt Hosp Ctr, New York,  New York,  10019,  United States
      Cornell Univ Med College / New York Hosp, New York,  New York,  10021,  United States
Pennsylvania
      Univ of Pittsburgh / Graduate School of Public Health, Pittsburgh,  Pennsylvania,  15261,  United States
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Oak Lawn Physicians Group, Dallas,  Texas,  75219,  United States
      Infectious Diseases Association of Houston, Houston,  Texas,  77030,  United States

Study ID Numbers:  059D; ICM 1654
Record last reviewed:  November 1993
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002095
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08