A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

HIV Infections Clinical Trial

Official title:

A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002095
• Other study ID #: 059D
• Secondary ID: ICM 1654
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 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 evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical or ophthalmic nucleoside analogs.

Patients must have:

• Confirmation of HIV infection.

• Documented CMV infection.

• No past or present CMV disease (e.g., retinitis, colitis, esophagitis).

• Adequate visualization of the retina of both eyes by ophthalmologist.

• CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).

• Inability to comply with protocol.

Concurrent Medication:

Excluded:

• The following nucleoside analogs:

• IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.

• FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.

• Imipenem-cilastatin (Primaxin).

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir.

Prior Medication:

Excluded within the past 60 days:

Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Cytomegalovirus Infections
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
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	Community Research Initiative	Coral Gables	Florida
United States	Oak Lawn Physicians Group	Dallas	Texas
United States	Infectious Diseases Association of Houston	Houston	Texas
United States	Kraus - Beer Med Group	Los Angeles	California
United States	Cornell Univ Med College / New York Hosp	New York	New York
United States	Kaplan Cancer Ctr / New York Univ Med Ctr	New York	New York
United States	St Lukes - Roosevelt Hosp Ctr	New York	New York
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Univ of Pittsburgh / Graduate School of Public Health	Pittsburgh	Pennsylvania
United States	UCSD	San Diego	California
United States	Davies Med Ctr / c/o HIV Institute	San Francisco	California
United States	Mount Zion Med Ctr	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. — View Citation