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



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

For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Roche Global Development ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented AIDS diagnosis. - Newly diagnosed peripheral CMV retinitis. More than 3 weeks of previous therapy for CMV retinitis.
Total Enrollment: 70

Location and Contact Information:

Duke Univ Eye Ctr
Durham,  North Carolina,  27710
United States
 

Davies Med Ctr / Institute for HIV Research
San Francisco,  California,  94114
United States
 

Emory Eye Clinic
Atlanta,  Georgia,  30322
United States
 

QUEST Clinical Research
San Francisco,  California,  94115
United States
 

Univ of California / San Diego / Dept of Pediatrics
La Jolla,  California,  92093
United States
 

New York Hosp - Cornell Med Ctr
New York City,  New York,  10021
United States
 

The Toronto Hosp / Dept of Infectious Disease
Toronto,  Ontario, 
Canada
 

Univ of Miami School of Medicine
Miami,  Florida,  33136
United States
 

Univ of California / Irvine
Irvine,  California,  92697
United States
 

St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
New York City,  New York,  10019
United States
 

Univ of California / San Diego Treatment Ctr
San Diego,  California,  92103
United States
 

Montreal Chest Institute
Montreal,  Quebec, 
Canada
 

New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Austin Infectious Disease Consultants
Austin,  Texas,  78705
United States
 

Royal Victoria Hosp
Montreal,  Quebec, 
Canada
 

New England Med Ctr
Boston,  Massachusetts,  02111
United States
 

Kaiser Permanente Med Ctr
San Francisco,  California,  94115
United States
 

St Pauls Hosp
Vancouver,  British Columbia, 
Canada
 

Dr Alan Palestine
Washington D.C.,  District of Columbia,  20006
United States
 


Additional Information:
Study ID Numbers:
  268A;  WV15376B
Study Start Date: 
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002377

Other Hiv Infections Studies:
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2. A Study of Patients Who Recently Have Been Infected with HIV

3. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma

4. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy

5. A Comparison of Zidovudine (AZT) Used Alone or in Combination with Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

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

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