A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Completed · Phase 3

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000688

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

180

Last updated by the study team

2011-03-14

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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