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

NCT ID: NCT00002377

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2002-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Retinitis HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Valganciclovir

Intervention Type DRUG

Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented AIDS diagnosis
* Newly diagnosed peripheral CMV retinitis
* More than 3 weeks of previous therapy for CMV retinitis
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Univ of California / Irvine

Irvine, California, United States

Site Status

Univ of California / San Diego / Dept of Pediatrics

La Jolla, California, United States

Site Status

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Site Status

Davies Med Ctr / Institute for HIV Research

San Francisco, California, United States

Site Status

Kaiser Permanente Med Ctr

San Francisco, California, United States

Site Status

QUEST Clinical Research

San Francisco, California, United States

Site Status

Dr Alan Palestine

Washington D.C., District of Columbia, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Emory Eye Clinic

Atlanta, Georgia, United States

Site Status

New England Med Ctr

Boston, Massachusetts, United States

Site Status

New York Univ Med Ctr

New York, New York, United States

Site Status

St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis

New York, New York, United States

Site Status

New York Hosp - Cornell Med Ctr

New York, New York, United States

Site Status

Duke Univ Eye Ctr

Durham, North Carolina, United States

Site Status

Austin Infectious Disease Consultants

Austin, Texas, United States

Site Status

St Pauls Hosp

Vancouver, British Columbia, Canada

Site Status

The Toronto Hosp / Dept of Infectious Disease

Toronto, Ontario, Canada

Site Status

Montreal Chest Institute

Montreal, Quebec, Canada

Site Status

Royal Victoria Hosp

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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WV15376

Identifier Type: -

Identifier Source: org_study_id

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