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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00002377

Collaborator

(none)

Locations

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Valganciclovir Drug: Ganciclovir	Phase 3

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Actual Study Start Date :

Jan 1, 1997

Actual Primary Completion Date :

Dec 1, 2002

Actual Study Completion Date :

Dec 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of California / Irvine	Irvine	California	United States	92697
2	Univ of California / San Diego / Dept of Pediatrics	La Jolla	California	United States	92093
3	Univ of California / San Diego Treatment Ctr	San Diego	California	United States	92103
4	Davies Med Ctr / Institute for HIV Research	San Francisco	California	United States	94114
5	Kaiser Permanente Med Ctr	San Francisco	California	United States	94115
6	QUEST Clinical Research	San Francisco	California	United States	94115
7	Dr Alan Palestine	Washington, D.C.	District of Columbia	United States	20006
8	Univ of Miami School of Medicine	Miami	Florida	United States	33136
9	Emory Eye Clinic	Atlanta	Georgia	United States	30322
10	New England Med Ctr	Boston	Massachusetts	United States	02111
11	New York Univ Med Ctr	New York	New York	United States	10016
12	St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis	New York	New York	United States	10019
13	New York Hosp - Cornell Med Ctr	New York	New York	United States	10021
14	Duke Univ Eye Ctr	Durham	North Carolina	United States	27710
15	Austin Infectious Disease Consultants	Austin	Texas	United States	78705
16	St Pauls Hosp	Vancouver	British Columbia	Canada
17	The Toronto Hosp / Dept of Infectious Disease	Toronto	Ontario	Canada
18	Montreal Chest Institute	Montreal	Quebec	Canada
19	Royal Victoria Hosp	Montreal	Quebec	Canada