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

NCT ID: NCT00002247

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Detailed Description

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.

Conditions

Cytomegalovirus Retinitis; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

Ganciclovir

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
• ddI.
• ddC.

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 consent.

Exclusion Criteria

Co-existing Condition:

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 disease.
• Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
• Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment).
• 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 protocol.

Concurrent Medication:

Excluded:

• Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy.
• Antimetabolites.
• 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).

Prior Medication:

Excluded:

• More than two induction treatment regimens with IV ganciclovir.
• Prior oral ganciclovir (in Groups A, B, and C only).

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Locations

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

San Francisco Gen Hosp

San Francisco, California, United States

Davies Med Ctr / c/o HIV Institute

San Francisco, California, United States

Mount Zion Med Ctr

San Francisco, California, United States

Dr David Busch

San Francisco, California, United States

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Miami Veterans Administration Med Ctr

Miami, Florida, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Margo Heath - Chiozzi

Honolulu, Hawaii, United States

Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll

Chicago, Illinois, United States

Beth Israel Hosp

Boston, Massachusetts, United States

Dr Dorothy Friedberg

New York, New York, United States

Cornell Univ Med College

New York, New York, United States

Buckley Braffman Stern Med Associates

Philadelphia, Pennsylvania, United States

Oak Lawn Physicians Group

Dallas, Texas, United States

Univ TX Galveston Med Branch

Galveston, Texas, United States

Univ of Washington / Pacific Med Ctr

Seattle, Washington, United States

Saint Paul's Hosp

Vancouver, British Columbia, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 9110064 (View on PubMed)

Other Identifiers

ICM 1774

Identifier Type: -

Identifier Source: secondary_id

059C

Identifier Type: -

Identifier Source: org_study_id