A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections
Intervention: Ganciclovir (Drug)
Sponsored by: Hoffmann-La Roche
To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a
single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To
compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of
oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To
describe the efficacy and safety of double dose versus single dose oral ganciclovir in
patients who have a progression of retinitis while on the originally assigned maintenance
treatment. To describe the safety, tolerance, and time to progression of retinitis during the
52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety
and tolerance of oral ganciclovir maintenance therapy when given concurrently with
antiretroviral treatment (e. g., zidovudine, ddI, or ddC). To describe survival of people with
AIDS and CMV retinitis.
Official title: A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Study design: Treatment, Randomized, Safety Study
Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in
Groups A, B, and C of the study, provided that each subject has received and tolerated a
therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in
stable retinitis. An additional 100 subjects who have received and tolerated a course of IV
or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research
and have stable retinitis may enter into Group D of this study and receive oral ganciclovir.
Minimum age: 13 Years.
Maximum age: N/A.
- Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance
Patients must have:
- Confirmed HIV infection or diagnosis of AIDS.
- CMV retinitis of no more than 4 months duration.
- Stable retinitis.
- Understanding of the nature of the study, agree to its provisions, and sign informed
Patients with the following symptoms and conditions are excluded:
- Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea,
or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal
- Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic
- Ocular conditions requiring immediate surgical correction (e. g., retinal tear or
- Dementia, decreased mentation, or other encephalopathic signs and symptoms that would
interfere with the ability of the subject to give informed consent or comply with the
- Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance
- Alkylating agents.
- Selected nucleoside analogs.
- Selected cytokines.
Patients with the following prior conditions are excluded:
- Diagnosis of CMV retinitis more than 4 months prior to study entry.
- More than two prior induction treatments of IV ganciclovir (initial induction and one
re-induction are permitted).
- More than two induction treatment regimens with IV ganciclovir.
- Prior oral ganciclovir (in Groups A, B, and C only).
Locations and Contacts
Saint Paul's Hosp, Vancouver, British Columbia, Canada
San Francisco Gen Hosp, San Francisco, California 941102859, United States
Davies Med Ctr / c/o HIV Institute, San Francisco, California 94114, United States
UCSD Med Ctr / Pediatrics, San Diego, California 92103, United States
East Bay AIDS Ctr, Berkeley, California 94704, United States
Mount Zion Med Ctr, San Francisco, California 94115, United States
Dr David Busch, San Francisco, California 94118, United States
AIDS Clinical Research Ctr / UCLA Med Ctr, Los Angeles, California 900951793, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
Margo Heath - Chiozzi, Honolulu, Hawaii 96816, United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll, Chicago, Illinois 60612, United States
Beth Israel Hosp, Boston, Massachusetts 02215, United States
Dr Dorothy Friedberg, New York, New York 10016, United States
Cornell Univ Med College, New York, New York 10021, United States
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Oak Lawn Physicians Group, Dallas, Texas 75219, United States
Univ of Washington / Pacific Med Ctr, Seattle, Washington 98144, United States
Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS. 1996 Dec;10 Suppl 4:S7-11.
Last updated: June 23, 2005