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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 |
| MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
| Drug Information available for: | Ganciclovir Ganciclovir sodium Valganciclovir Valganciclovir hydrochloride |
| 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 | |||||
| Hoffmann-La Roche |
More Information
| Study ID Numbers: | WV15376 |
| First Received: | November 2, 1999 |
| Last Updated: | July 1, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002377 |
| Health Authority: | United States: Food and Drug Administration |
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