A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

Completed · Not applicable

Conditions studied: Cytomegalovirus Infections, HIV Infections

In brief

To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts \<= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.

Key facts

Study ID

NCT00002095

Run by

Hoffmann-La Roche

People needed

700

Last updated by the study team

2005-06-24

Who can join

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

You may qualify if…

• Concurrent Medication:
• Allowed:
• Topical or ophthalmic nucleoside analogs.
• Patients must have:
• Confirmation of HIV infection.
• Documented CMV infection.
• No past or present CMV disease (e.g., retinitis, colitis, esophagitis).
• Adequate visualization of the retina of both eyes by ophthalmologist.
• CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).
• Inability to comply with protocol.
• Concurrent Medication:
• Excluded:
• The following nucleoside analogs:
• IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.
• FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.
• Imipenem-cilastatin (Primaxin).
• Patients with the following prior condition are excluded:
• History of hypersensitivity to acyclovir.
• Prior Medication:
• Excluded within the past 60 days:
• Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Kraus - Beer Med Group — Los Angeles, California, United States
• UCSD — San Diego, California, United States
• Davies Med Ctr / c/o HIV Institute — San Francisco, California, United States
• Mount Zion Med Ctr — San Francisco, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Community Research Initiative — Coral Gables, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll — Chicago, Illinois, United States
• Beth Israel Hosp — Boston, Massachusetts, United States
• Kaplan Cancer Ctr / New York Univ Med Ctr — New York, New York, United States
• St Lukes - Roosevelt Hosp Ctr — New York, New York, United States
• Cornell Univ Med College / New York Hosp — New York, New York, United States
• Buckley Braffman Stern Med Associates — Philadelphia, Pennsylvania, United States
• Univ of Pittsburgh / Graduate School of Public Health — Pittsburgh, Pennsylvania, United States
• Oak Lawn Physicians Group — Dallas, Texas, United States
• Infectious Diseases Association of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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