A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.

Key facts

Study ID

NCT00002330

Run by

Roche Global Development

People needed

280

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 and ophthalmic nucleoside analogues.
• Patients must have:
• HIV positive.
• No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
• Currently stable retinitis.
• Prior Medication:
• Allowed:
• Foscarnet prior to the 4 weeks of intravenous induction therapy.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Persistent or clinically significant diarrhea, nausea, or abdominal pain.
• Severe odynophagia.
• Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
• Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
• Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
• Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.
• Concurrent Medication:
• Excluded:
• Acyclovir sodium (Zovirax) by any route other than topical.
• Valacyclovir.
• Brovavir.
• Vidarabine.
• Amantadine hydrochloride.
• Cytarabine.
• Idoxuridine.
• Ribavirin.
• Interferon.
• Foscarnet (non-nucleoside pyrophosphate analogue).
• CMV hyperimmune globulin.
• Soluble CD4.
• Trichosanthin (Compound Q).
• Imipenem-cilastatin.
• Isoprinosine.

Where it is running

• Univ of Alabama at Birmingham / AIDS Outpatient Clinic — Birmingham, Alabama, United States
• McDowell Clinic — Phoenix, Arizona, United States
• Dr Ken Fisher — Phoenix, Arizona, United States
• Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States
• East Bay AIDS Ctr — Berkeley, California, United States
• AIDS Clinical Research Ctr / UCLA Med Ctr — Los Angeles, California, United States
• UCSD Med Ctr / Pediatrics — San Diego, California, United States
• Davies Med Ctr — San Francisco, California, United States
• Mount Zion Med Ctr / UCSF — San Francisco, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• George Washington 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
• Margo Heath - Chiozzi — Honolulu, Hawaii, United States
• Univ of Maryland School of Medicine — Baltimore, Maryland, United States
• AIDS Clinical Trials Unit — St Louis, Missouri, United States
• HIV Wellness Ctr / Univ Med Ctr — Las Vegas, Nevada, United States
• Univ of New Mexico — Albuquerque, New Mexico, United States
• AIDS Wellness Clinic — Sante Fe, New Mexico, United States
• Dr Dorothy Friedberg — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• New York Hosp - Cornell Med Ctr — New York, New York, United States
• Univ of North Carolina School of Medicine — Chapel Hill, North Carolina, United States
• Nalle Clinic — Charlotte, North Carolina, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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