To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression. The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.

Condition	Treatment or Intervention	Phase
Cytomegalovirus Retinitis HIV Infections Gastrointestinal Diseases	Drug: Ganciclovir	Phase II

Further Study Details: 

Expected Total Enrollment:  850

The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.

Patients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDMENT 5/2/95: After the common closing date (6/3/95) patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 8/31/95.

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

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Antiretroviral therapy.
• Anti-PCP prophylaxis.
• Maintenance or prophylaxis therapy for other opportunistic infections besides CMV. Patients must have:
• Working diagnosis of HIV infection.
• CD4 count <= 100 cells/mm3.
• Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry.
• Reasonably good health.
• Life expectancy of at least 6 months.

Exclusion Criteria

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

• Acute life-threatening illness.
• Active lymphoma.
• Hypersensitivity to acyclovir.
• Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements.

Concurrent Medication: Excluded:

• Vidarabine.
• Amantadine hydrochloride (Symmetrel).
• CMV hyperimmune globulin/intravenous immune globulin.
• Cytarabine.
• Fiacitabine (FIAC) or fialuridine (FIAU).
• Foscarnet.
• Intravenous ganciclovir.
• HPMPC.
• Idoxuridine.
• Intravenous acyclovir.
• Oral acyclovir at > 1 g/day.
• Other drugs with potential anti-CMV activity.

Prior Medication: Excluded within 60 days prior to study entry:

• Foscarnet.

Excluded within 2 weeks prior to study entry:

• Vidarabine.
• Amantadine hydrochloride (Symmetrel).
• CMV hyperimmune globulin/intravenous immune globulin.
• Cytarabine.
• Fiacitabine (FIAC) or fialuridine (FIAU).
• Ganciclovir.
• HPMPC.
• Idoxuridine.
• Intravenous acyclovir.
• Oral acyclovir at > 1 g/day.
• Other drugs with potential anti-CMV activity.

California
      Community Consortium of San Francisco, San Francisco,  California,  94110,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
Delaware
      Wilmington Hosp / Med Ctr of Delaware, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Veterans Administration Med Ctr / Regional AIDS Program, Washington,  District of Columbia,  20422,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Comprehensive AIDS Alliance of Detroit, Detroit,  Michigan,  48201,  United States
New Jersey
      Schering - Plough Corp, Kenilworth,  New Jersey,  07033,  United States
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
New York
      Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York,  New York,  10037,  United States
      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10456,  United States
      Clinical Directors Network of Region II, New York,  New York,  10011,  United States
      Addiction Research and Treatment Corp, Brooklyn,  New York,  11201,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  972109951,  United States
Virginia
      Richmond AIDS Consortium, Richmond,  Virginia,  23298,  United States

Study chairs or principal investigators

Brosgart C,  Study Chair
Craig C,  Study Chair

Study ID Numbers:  CPCRA 023
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001034
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08