A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
3 other identifiers
interventional
180
1 country
22
Brief Summary
To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
February 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 14, 2011
October 1, 1990
November 2, 1999
March 11, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Pacific Presbyterian
San Francisco, California, 94118, United States
Mills Hosp
San Mateo, California, 94401, United States
Stanford Univ School of Medicine
Stanford, California, 94305, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Kansas City Veterans Administration Med Ctr
Kansas City, Missouri, 64128, United States
Washington Univ Med Ctr
St Louis, Missouri, 63110, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131, United States
New York Univ Med Ctr / Dept of Environmental Med
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Plaza Med Ctr
Houston, Texas, 77004, United States
Infectious Diseases Association of Houston / Methodist Hosp
Houston, Texas, 77030, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Related Publications (1)
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.
PMID: 8394858BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Spector SA
- STUDY CHAIR
Jabs D
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
February 1, 1995
Last Updated
March 14, 2011
Record last verified: 1990-10