Clinical trial NCT00002134: A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Official title: A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Ganciclovir
Administration, Oral
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 450
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.

Detailed description: Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical drugs and ophthalmics.

Patients must have:

* AIDS.
* Unilateral CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
* Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
* Acute retinal necrosis or any other intraocular condition that might preclude study completion.
* Ocular condition requiring immediate surgery.
* Unable to have long-term IV catheter placement.

Concurrent Medication:

Excluded:

* Vidarabine.
* Amantadine hydrochloride.
* Cytarabine.
* FIAC or FIAU.
* Idoxuridine.
* Ribavirin.
* Valacyclovir.
* Foscarnet.
* CMV hyperimmune globulin.
* Soluble CD4.
* Trichosanthin.
* Imipenem-cilastatin.
* Isoprinosine.
* Levamisole.
* Interferon.
* Other investigational drugs.

Patients with the following prior conditions are excluded:

* History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
* History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

* Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
* Prior intravitreal ganciclovir implant.
* More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
* Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Dr Neil Brourman
state: California
city: Irvine
country: United States
facility: UCI College of Medicine
state: California
city: Los Angeles
country: United States
facility: Estelle Doheny Eye Clinic
state: California
city: Sacramento
country: United States
facility: Dr Robert T Wendel
state: California
city: San Francisco
country: United States
facility: Kaiser Hosp
state: California
city: San Francisco
country: United States
facility: Pacific Horizons Med Group
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Med Ctr
state: California
city: Santa Barbara
country: United States
facility: Dr Robert Avery
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Washington
country: United States
facility: Dr Alan Palestine
state: District of Columbia
city: Jacksonville
country: United States
facility: Dr Michael Stewart
state: Florida
city: Miami
country: United States
facility: Bascom Palmer
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Clinic
state: Georgia
city: Chicago
country: United States
facility: Dr David Weinberg
state: Illinois
city: Lexington
country: United States
facility: Univ of Kentucky Med Ctr
state: Kentucky
city: Boston
country: United States
facility: New England Med Ctr / Tufts Univ
state: Massachusetts
city: New York
country: United States
facility: Dr Dorothy Friedberg
state: New York
city: New York
country: United States
facility: Saint Clare's Prof Office
state: New York
city: New York
country: United States
facility: New York Hosp
state: New York
city: New York
country: United States
facility: Vitreo - Retinal Consultants
state: New York
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Univ of Washington Med Ctr
state: Washington
Study officials:
References:
citation: Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4.