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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002134
• Other study ID #: 037B
• Secondary ID: GANS2304
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1997
• 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
United States	Emory Eye Clinic	Atlanta	Georgia
United States	Dr Neil Brourman	Beverly Hills	California
United States	New England Med Ctr / Tufts Univ	Boston	Massachusetts
United States	Dr David Weinberg	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	UCI College of Medicine	Irvine	California
United States	Dr Michael Stewart	Jacksonville	Florida
United States	Univ of Kentucky Med Ctr	Lexington	Kentucky
United States	Estelle Doheny Eye Clinic	Los Angeles	California
United States	Bascom Palmer	Miami	Florida
United States	Dr Dorothy Friedberg	New York	New York
United States	New York Hosp	New York	New York
United States	Saint Clare's Prof Office	New York	New York
United States	Vitreo - Retinal Consultants	New York	New York
United States	Dr Robert T Wendel	Sacramento	California
United States	Kaiser Hosp	San Francisco	California
United States	Pacific Horizons Med Group	San Francisco	California
United States	Santa Clara Valley Med Ctr	San Jose	California
United States	Dr Robert Avery	Santa Barbara	California
United States	Univ of Washington Med Ctr	Seattle	Washington
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Dr Alan Palestine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Roche Global Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4. — View Citation