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A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Phase 3
Completed
Conditions
Cytomegalovirus Retinitis
HIV Infections
Registration Number
NCT00000688
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

Detailed Description

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
180
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (22)

Univ of California / San Diego Treatment Ctr

🇺🇸

San Diego, California, United States

Stanford Univ School of Medicine

🇺🇸

Stanford, California, United States

Kansas City Veterans Administration Med Ctr

🇺🇸

Kansas City, Missouri, United States

Pacific Presbyterian

🇺🇸

San Francisco, California, United States

George Washington Univ Med Ctr

🇺🇸

Washington, District of Columbia, United States

Cornell Univ Med Ctr

🇺🇸

New York, New York, United States

Indiana Univ Hosp

🇺🇸

Indianapolis, Indiana, United States

New York Univ Med Ctr / Dept of Environmental Med

🇺🇸

New York, New York, United States

Henry Ford Hosp

🇺🇸

Detroit, Michigan, United States

Univ of Minnesota

🇺🇸

Minneapolis, Minnesota, United States

Mills Hosp

🇺🇸

San Mateo, California, United States

Infectious Disease Physicians Inc

🇺🇸

Annandale, Virginia, United States

Washington Univ Med Ctr

🇺🇸

St Louis, Missouri, United States

Mount Zion Med Ctr

🇺🇸

San Francisco, California, United States

Infectious Diseases Association of Houston / Methodist Hosp

🇺🇸

Houston, Texas, United States

Holmes Hosp / Univ of Cincinnati Med Ctr

🇺🇸

Cincinnati, Ohio, United States

Univ of New Mexico Hlth Sciences Ctr / Dept of Med

🇺🇸

Albuquerque, New Mexico, United States

Univ TX Galveston Med Branch

🇺🇸

Galveston, Texas, United States

Plaza Med Ctr

🇺🇸

Houston, Texas, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr

🇺🇸

San Francisco, California, United States

Northwestern Univ Med School

🇺🇸

Chicago, Illinois, United States

Rush Presbyterian - Saint Luke's Med Ctr

🇺🇸

Chicago, Illinois, United States

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