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NCT00002377 Clinical Trial

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

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002377
Other study ID # WV15376
Secondary ID
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated May 15, 2017
Start date January 1997
Est. completion date December 2002

Study information
Verified date July 2005
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2002
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria:

- Documented AIDS diagnosis

- Newly diagnosed peripheral CMV retinitis

- More than 3 weeks of previous therapy for CMV retinitis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valganciclovir

• Ganciclovir

Locations
Country Name City State
Canada Montreal Chest Institute Montreal Quebec
Canada Royal Victoria Hosp Montreal Quebec
Canada The Toronto Hosp / Dept of Infectious Disease Toronto Ontario
Canada St Pauls Hosp Vancouver British Columbia
United States Emory Eye Clinic Atlanta Georgia
United States Austin Infectious Disease Consultants Austin Texas
United States New England Med Ctr Boston Massachusetts
United States Duke Univ Eye Ctr Durham North Carolina
United States Univ of California / Irvine Irvine California
United States Univ of California / San Diego / Dept of Pediatrics La Jolla California
United States Univ of Miami School of Medicine Miami Florida
United States New York Hosp - Cornell Med Ctr New York New York
United States New York Univ Med Ctr New York New York
United States St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis New York New York
United States Univ of California / San Diego Treatment Ctr San Diego California
United States Davies Med Ctr / Institute for HIV Research San Francisco California
United States Kaiser Permanente Med Ctr San Francisco California
United States QUEST Clinical Research San Francisco California
United States Dr Alan Palestine Washington, D.C. District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

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