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	Treatment or Intervention	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Valganciclovir  Drug: Ganciclovir	Phase II

Further Study Details: 

Expected Total Enrollment:  70

Patients will be randomized to 1 of 2 treatment groups. Group A will receive iv ganciclovir for 3 weeks, then iv ganciclovir for 1 week. Group B will receive RS-79070 bid for 3 weeks then RS-790070 qd for 1 week. After the initial 4 week treatment period, patients from both groups will then be offered entry into a long-term follow-up phase of the study where they will receive RS-79070 qd.

Ages Eligible for Study:  14 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• Documented AIDS diagnosis.
• Newly diagnosed peripheral CMV retinitis.

More than 3 weeks of previous therapy for CMV retinitis.

California
      Davies Med Ctr / Institute for HIV Research, San Francisco,  California,  94114,  United States
      Univ of California / Irvine, Irvine,  California,  92697,  United States
      QUEST Clinical Research, San Francisco,  California,  94115,  United States
      Univ of California / San Diego Treatment Ctr, San Diego,  California,  92103,  United States
      Univ of California / San Diego / Dept of Pediatrics, La Jolla,  California,  92093,  United States
      Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
District of Columbia
      Dr Alan Palestine, Washington,  District of Columbia,  20006,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
Georgia
      Emory Eye Clinic, Atlanta,  Georgia,  30322,  United States
Massachusetts
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States
New York
      New York Hosp - Cornell Med Ctr, New York,  New York,  10021,  United States
      St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis, New York,  New York,  10019,  United States
      New York Univ Med Ctr, New York,  New York,  10016,  United States
North Carolina
      Duke Univ Eye Ctr, Durham,  North Carolina,  27710,  United States
Texas
      Austin Infectious Disease Consultants, Austin,  Texas,  78705,  United States
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

Study ID Numbers:  268A; WV15376B
Record last reviewed:  April 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002377
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08