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
NCT ID: NCT00001034
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
850 participants
INTERVENTIONAL
1995-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Ganciclovir
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Brosgart C
Role: STUDY_CHAIR
Craig C
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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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.
Other Identifiers
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11573
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 023
Identifier Type: -
Identifier Source: org_study_id