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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

NCT00001034

CompletedPhase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: Cytomegalovirus Retinitis, HIV Infections, Gastrointestinal Diseases

Interventions: Ganciclovir

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (17)

San Francisco, California, United States
Denver, Colorado, United States
Wilmington, Delaware, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Kenilworth, New Jersey, United States
Newark, New Jersey, United States
Brooklyn, New York, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Portland, Oregon, United States
Richmond, Virginia, United States