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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00002377 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, California | |
| Davies Med Ctr / Institute for HIV Research | |
| San Francisco, California, United States, 94114 | |
| Univ of California / Irvine | |
| Irvine, California, United States, 92697 | |
| QUEST Clinical Research | |
| San Francisco, California, United States, 94115 | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 92103 | |
| Univ of California / San Diego / Dept of Pediatrics | |
| La Jolla, California, United States, 92093 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| 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 | |
More Information
| Study ID Numbers: | WV15376 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 1, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002377 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Valganciclovir Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Antiviral Agents Cytomegalovirus |
Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections Retinal Diseases |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Valganciclovir Retinitis Infection Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Retinal Diseases RNA Virus Infections Immune System Diseases Eye Infections, Viral Eye Diseases |
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |
