A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
NCT ID: NCT00000688
Last Updated: 2011-03-14
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
PHASE3
180 participants
INTERVENTIONAL
Brief Summary
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CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.
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Detailed Description
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Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.
Conditions
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Study Design
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TREATMENT
Interventions
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Ganciclovir
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir.
* Didanosine (ddI) may be continued or initiated in any patient during the study.
* Topical acyclovir.
* Topical ophthalmics.
* Aerosolized pentamidine.
Patients must have:
* AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV.
* Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea.
* Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex.
* Life expectancy of at least 4 months.
Exclusion Criteria
Patients with ocular conditions requiring immediate surgical correction are excluded.
Concurrent Medication:
Excluded during first 4 weeks of ganciclovir treatment:
Zidovudine (AZT).
Excluded:
Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines.
Patients with the following are excluded:
* Immediately sight-threatening retinitis (= or \< 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or \< 3000 microns from the fovea).
* Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment.
* Demonstrated hypersensitivity to acyclovir.
Prior Medication:
Excluded:
\- Previous treatment with anti-cytomegalovirus therapy.
13 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Spector SA
Role: STUDY_CHAIR
Jabs D
Role: STUDY_CHAIR
Locations
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Univ of California / San Diego Treatment Ctr
San Diego, California, United States
Mount Zion Med Ctr
San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States
Pacific Presbyterian
San Francisco, California, United States
Mills Hosp
San Mateo, California, United States
Stanford Univ School of Medicine
Stanford, California, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Henry Ford Hosp
Detroit, Michigan, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Kansas City Veterans Administration Med Ctr
Kansas City, Missouri, United States
Washington Univ Med Ctr
St Louis, Missouri, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States
New York Univ Med Ctr / Dept of Environmental Med
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Plaza Med Ctr
Houston, Texas, United States
Infectious Diseases Association of Houston / Methodist Hosp
Houston, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Countries
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References
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Spector SA, Weingeist T, Pollard RB, Dieterich DT, Samo T, Benson CA, Busch DF, Freeman WR, Montague P, Kaplan HJ, et al. A randomized, controlled study of intravenous ganciclovir therapy for cytomegalovirus peripheral retinitis in patients with AIDS. AIDS Clinical Trials Group and Cytomegalovirus Cooperative Study Group. J Infect Dis. 1993 Sep;168(3):557-63. doi: 10.1093/infdis/168.3.557.
Other Identifiers
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RS-21592
Identifier Type: -
Identifier Source: secondary_id
ICM 1697
Identifier Type: -
Identifier Source: secondary_id
ACTG 071
Identifier Type: -
Identifier Source: org_study_id
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