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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002247
• Other study ID #: 059C
• Secondary ID: ICM 1774
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
Canada	Saint Paul's Hosp	Vancouver	British Columbia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Beth Israel Hosp	Boston	Massachusetts
United States	Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll	Chicago	Illinois
United States	Oak Lawn Physicians Group	Dallas	Texas
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Margo Heath - Chiozzi	Honolulu	Hawaii
United States	AIDS Clinical Research Ctr / UCLA Med Ctr	Los Angeles	California
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Cornell Univ Med College	New York	New York
United States	Dr Dorothy Friedberg	New York	New York
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	UCSD Med Ctr / Pediatrics	San Diego	California
United States	Davies Med Ctr / c/o HIV Institute	San Francisco	California
United States	Dr David Busch	San Francisco	California
United States	Mount Zion Med Ctr	San Francisco	California
United States	San Francisco Gen Hosp	San Francisco	California
United States	Univ of Washington / Pacific Med Ctr	Seattle	Washington
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation