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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002095
• Date of registration: 02/11/1999
• Primary sponsor: Hoffmann-La Roche
• Public 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
• Scientific 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
• Date of first enrolment: January 1976
• Target sample size: 700
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002095
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cytomegalovirus Infections

HIV Infections

Intervention(s)

Drug: Ganciclovir

Secondary ID(s)

059D

ICM 1654

Source(s) of Monetary Support

Please refer to primary and secondary sponsors