A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00002377
First received: November 2, 1999
Last updated: July 1, 2005
Last verified: July 2005
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Purpose
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 | Intervention | Phase |
---|---|---|
Cytomegalovirus Retinitis HIV Infections |
Drug: Valganciclovir Drug: Ganciclovir |
Phase 3 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Eligibility
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented AIDS diagnosis
- Newly diagnosed peripheral CMV retinitis
- More than 3 weeks of previous therapy for CMV retinitis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002377
Locations
United States, California | |
Univ of California / Irvine | |
Irvine, California, United States, 92697 | |
Univ of California / San Diego / Dept of Pediatrics | |
La Jolla, California, United States, 92093 | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 92103 | |
QUEST Clinical Research | |
San Francisco, California, United States, 94115 | |
Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
Davies Med Ctr / Institute for HIV Research | |
San Francisco, California, United States, 94114 | |
United States, District of Columbia | |
Dr Alan Palestine | |
Washington, District of Columbia, United States, 20006 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Emory Eye Clinic | |
Atlanta, Georgia, United States, 30322 | |
United States, Massachusetts | |
New England Med Ctr | |
Boston, Massachusetts, United States, 02111 | |
United States, New York | |
New York Hosp - Cornell Med Ctr | |
New York, New York, United States, 10021 | |
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis | |
New York, New York, United States, 10019 | |
New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Duke Univ Eye Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Texas | |
Austin Infectious Disease Consultants | |
Austin, Texas, United States, 78705 | |
Canada, British Columbia | |
St Pauls Hosp | |
Vancouver, British Columbia, Canada | |
Canada, Ontario | |
The Toronto Hosp / Dept of Infectious Disease | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
Montreal Chest Institute | |
Montreal, Quebec, Canada | |
Royal Victoria Hosp | |
Montreal, Quebec, Canada |
Sponsors and Collaborators
Hoffmann-La Roche
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2013
No publications provided
ClinicalTrials.gov Identifier: | NCT00002377 History of Changes |
Other Study ID Numbers: | WV15376 |
Study First Received: | November 2, 1999 |
Last Updated: | July 1, 2005 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Valganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013