- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001034
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
A Randomized, Comparative, Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus (CMV) Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression
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.
Study Overview
Status
Intervention / Treatment
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 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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94110
- Community Consortium of San Francisco
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Colorado
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Denver, Colorado, United States, 80204
- Denver CPCRA / Denver Public Hlth
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Delaware
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Wilmington, Delaware, United States, 19899
- Wilmington Hosp / Med Ctr of Delaware
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Veterans Administration Med Ctr / Regional AIDS Program
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Georgia
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Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta
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Illinois
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Chicago, Illinois, United States, 60657
- AIDS Research Alliance - Chicago
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hosp
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Detroit, Michigan, United States, 48201
- Comprehensive AIDS Alliance of Detroit
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New Jersey
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Kenilworth, New Jersey, United States, 07033
- Schering - Plough Corp
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Newark, New Jersey, United States, 07103
- North Jersey Community Research Initiative
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New York
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Bronx, New York, United States, 10456
- Bronx Lebanon Hosp Ctr
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Brooklyn, New York, United States, 11201
- Addiction Research and Treatment Corp
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New York, New York, United States, 10011
- Clinical Directors Network of Region II
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New York, New York, United States, 10037
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
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Oregon
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Portland, Oregon, United States, 97210
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Virginia
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Richmond, Virginia, United States, 23298
- Richmond AIDS Consortium
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Brosgart C
- Study Chair: Craig C
Publications and helpful links
General Publications
- Brosgart C, Craig C, Louis TA, Hillman D, Costanzo L, Timpone J, Scott J, Nunley F, Stempien MJ. Design and demographics in a multicenter trial of cytomegalovirus (CMV) prophylaxis in advanced HIV disease. Int Conf AIDS. 1994 Aug 7-12;10(2):10 (abstract no 331B)
- Brosgart CL, Louis TA, Hillman DW, Craig CP, Alston B, Fisher E, Abrams DI, Luskin-Hawk RL, Sampson JH, Ward DJ, Thompson MA, Torres RA. A randomized, placebo-controlled trial of the safety and efficacy of oral ganciclovir for prophylaxis of cytomegalovirus disease in HIV-infected individuals. Terry Beirn Community Programs for Clinical Research on AIDS. AIDS. 1998 Feb 12;12(3):269-77. doi: 10.1097/00002030-199803000-00004.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Eye Diseases
- Retinal Diseases
- DNA Virus Infections
- Herpesviridae Infections
- Eye Infections
- Eye Infections, Viral
- Retinitis
- Gastrointestinal Diseases
- Digestive System Diseases
- Cytomegalovirus Infections
- Cytomegalovirus Retinitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Ganciclovir
- Ganciclovir triphosphate
Other Study ID Numbers
- CPCRA 023
- 11573 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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