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.

Study Timeline

• Status Verified: 1990-10
• Primary Completion: 1995-02
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2011-03-11
• Last Update Posted: 2011-03-14

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

Trial Locations

Locations (22)

Univ of California / San Diego Treatment Ctr; 🇺🇸 San Diego, California, United States

Mount Zion Med Ctr; 🇺🇸 San Francisco, California, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

Pacific Presbyterian; 🇺🇸 San Francisco, California, United States

Mills Hosp; 🇺🇸 San Mateo, California, United States

Stanford Univ School of Medicine; 🇺🇸 Stanford, California, United States

George Washington Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Northwestern Univ Med School; 🇺🇸 Chicago, Illinois, United States

Rush Presbyterian - Saint Luke's Med Ctr; 🇺🇸 Chicago, Illinois, United States

Indiana Univ Hosp; 🇺🇸 Indianapolis, Indiana, United States

Scroll for more (12 remaining)