Clinical trial NCT00002247: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Ganciclovir
Cytomegalovirus Infections
Administration, Oral
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 225
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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).

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