A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes

Phase 3

Completed

• Conditions: Cytomegalovirus Retinitis; HIV Infections

• Registration Number: NCT00002377
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-01
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Status Verified: 2005-07
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Documented AIDS diagnosis
• Newly diagnosed peripheral CMV retinitis
• More than 3 weeks of previous therapy for CMV retinitis

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (19)

Univ of California / San Diego / Dept of Pediatrics; 🇺🇸 La Jolla, California, United States

St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis; 🇺🇸 New York, New York, United States

New York Hosp - Cornell Med Ctr; 🇺🇸 New York, New York, United States

Univ of California / San Diego Treatment Ctr; 🇺🇸 San Diego, California, United States

Emory Eye Clinic; 🇺🇸 Atlanta, Georgia, United States

Univ of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Dr Alan Palestine; 🇺🇸 Washington, D.C., District of Columbia, United States

New England Med Ctr; 🇺🇸 Boston, Massachusetts, United States

The Toronto Hosp / Dept of Infectious Disease; 🇨🇦 Toronto, Ontario, Canada

Montreal Chest Institute; 🇨🇦 Montreal, Quebec, Canada

St Pauls Hosp; 🇨🇦 Vancouver, British Columbia, Canada

Royal Victoria Hosp; 🇨🇦 Montreal, Quebec, Canada

Univ of California / Irvine; 🇺🇸 Irvine, California, United States

New York Univ Med Ctr; 🇺🇸 New York, New York, United States

Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

QUEST Clinical Research; 🇺🇸 San Francisco, California, United States

Austin Infectious Disease Consultants; 🇺🇸 Austin, Texas, United States

Davies Med Ctr / Institute for HIV Research; 🇺🇸 San Francisco, California, United States

Duke Univ Eye Ctr; 🇺🇸 Durham, North Carolina, United States