The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

Completed · Phase 2

Conditions studied: Cytomegalovirus Retinitis, HIV Infections, Gastrointestinal Diseases

In brief

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.

Key facts

Study ID

NCT00001034

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

850

Expected to finish

1995-08-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Community Consortium of San Francisco — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
• Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Schering - Plough Corp — Kenilworth, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Addiction Research and Treatment Corp — Brooklyn, New York, United States
• Clinical Directors Network of Region II — New York, New York, United States
• Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
• Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Richmond AIDS Consortium — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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