A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

HIV Infections Clinical Trial

Official title:

A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002330
• Other study ID #: 059F
• Secondary ID: GANs2226
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• 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 time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.

Description:

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical and ophthalmic nucleoside analogues.

Patients must have:

• HIV positive.

• No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.

• Currently stable retinitis.

Prior Medication:

Allowed:

• Foscarnet prior to the 4 weeks of intravenous induction therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Persistent or clinically significant diarrhea, nausea, or abdominal pain.

• Severe odynophagia.

• Other gastrointestinal (GI) symptoms or uncontrolled GI disease.

• Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).

• Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.

• Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.

Concurrent Medication:

Excluded:

• Acyclovir sodium (Zovirax) by any route other than topical.

• Valacyclovir.

• Brovavir.

• Vidarabine.

• Amantadine hydrochloride.

• Cytarabine.

• Idoxuridine.

• Ribavirin.

• Interferon.

• Foscarnet (non-nucleoside pyrophosphate analogue).

• CMV hyperimmune globulin.

• Soluble CD4.

• Trichosanthin (Compound Q).

• Imipenem-cilastatin.

• Isoprinosine.

• Levamisole.

• Other investigational drugs.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

• More than three induction regimens with intravenous anti-CMV therapy.

• Any prior oral ganciclovir.

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
Canada	Saint Paul's Hosp	Vancouver	British Columbia
United States	Univ of New Mexico	Albuquerque	New Mexico
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Austin Infectious Disease Consultants	Austin	Texas
United States	Univ of Maryland School of Medicine	Baltimore	Maryland
United States	East Bay AIDS Ctr	Berkeley	California
United States	Univ of Alabama at Birmingham / AIDS Outpatient Clinic	Birmingham	Alabama
United States	Univ of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Nalle Clinic	Charlotte	North Carolina
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	Ohio State Univ Hosp	Columbus	Ohio
United States	Community Research Initiative	Coral Gables	Florida
United States	N Texas Ctr for AIDS & Clin Rsch	Dallas	Texas
United States	Texas Tech Health Sciences Ctr	El Paso	Texas
United States	Dr Daniel Barbero	Fort Worth	Texas
United States	Margo Heath - Chiozzi	Honolulu	Hawaii
United States	Infectious Diseases Association of Houston	Houston	Texas
United States	HIV Wellness Ctr / Univ Med Ctr	Las Vegas	Nevada
United States	AIDS Clinical Research Ctr / UCLA Med Ctr	Los Angeles	California
United States	Dr Dorothy Friedberg	New York	New York
United States	New York Hosp - Cornell Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Dr Ken Fisher	Phoenix	Arizona
United States	McDowell Clinic	Phoenix	Arizona
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Audie L Murphy Veterans Administration Hosp	San Antonio	Texas
United States	UCSD Med Ctr / Pediatrics	San Diego	California
United States	Davies Med Ctr	San Francisco	California
United States	Mount Zion Med Ctr / UCSF	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	AIDS Wellness Clinic	Sante Fe	New Mexico
United States	AIDS Clinical Trials Unit	St. Louis	Missouri
United States	Univ of Arizona / Health Science Ctr	Tucson	Arizona
United States	Associates Med and Mental Health	Tulsa	Oklahoma
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Roche Global Development

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)