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

Not Applicable

Completed

• Conditions: Cytomegalovirus Infections; HIV Infections

• Registration Number: NCT00002095
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 1993-11
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (19)

East Bay AIDS Ctr; 🇺🇸 Berkeley, California, United States

Kraus - Beer Med Group; 🇺🇸 Los Angeles, California, 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, United States

Community Research Initiative; 🇺🇸 Coral Gables, Florida, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

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