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

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

Sponsors

Lead sponsor: Hoffmann-La Roche

Source NIH AIDS Clinical Trials Information Service
Brief 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.

Overall Status Completed
Phase N/A
Study Type Interventional
Enrollment 700
Condition
Intervention

Intervention type: Drug

Intervention name: Ganciclovir

Eligibility

Criteria:

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.

Gender: All

Minimum age: 13 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
East Bay AIDS Ctr | Berkeley, California, 94705, United States
Kraus - Beer Med Group | Los Angeles, California, 90028, United States
UCSD | San Diego, California, 92103, United States
Davies Med Ctr / c/o HIV Institute | San Francisco, California, 94114, United States
Mount Zion Med Ctr | San Francisco, California, 94115, United States
San Francisco Veterans Administration Med Ctr | San Francisco, California, 94121, United States
Harbor - UCLA Med Ctr | Torrance, California, 90502, United States
Georgetown Univ Med Ctr | Washington, District of Columbia, 20007, United States
Community Research Initiative | Coral Gables, Florida, 33146, United States
AIDS Research Consortium of Atlanta | Atlanta, Georgia, 30308, United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll | Chicago, Illinois, 60612, United States
Beth Israel Hosp | Boston, Massachusetts, 02215, United States
Kaplan Cancer Ctr / New York Univ Med Ctr | New York, New York, 10016, United States
St Lukes - Roosevelt Hosp Ctr | New York, New York, 10019, United States
Cornell Univ Med College / New York Hosp | New York, New York, 10021, United States
Buckley Braffman Stern Med Associates | Philadelphia, Pennsylvania, 19107, United States
Univ of Pittsburgh / Graduate School of Public Health | Pittsburgh, Pennsylvania, 15261, United States
Oak Lawn Physicians Group | Dallas, Texas, 75219, United States
Infectious Diseases Association of Houston | Houston, Texas, 77030, United States
Location Countries

United States

Verification Date

November 1993

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov