Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
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 immunosuppressio...
Detailed Description
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 effectiv...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 1995
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT00001034
End Date
August 1 1995
Last Update
November 4 2021
Active Locations (17)
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1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
3
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
4
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States, 20422