Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis

Phase 4

Completed

• Conditions: Cytomegalovirus Retinitis; HIV Infections

• Registration Number: NCT00000894
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.

Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.

Detailed Description

While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.

After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.

Study Timeline

• Study First Submitted: 1999-11-02
• Primary Completion: 2000-06
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2003-06
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (12)

Cornell Univ Med Ctr; 🇺🇸 New York, New York, United States

Julio Arroyo; 🇺🇸 West Columbia, South Carolina, United States

New York Hosp / Cornell Med Ctr; 🇺🇸 New York, New York, United States

Univ of Southern California / LA County USC Med Ctr; 🇺🇸 Los Angeles, California, United States

UCLA CARE Ctr; 🇺🇸 Los Angeles, California, United States

Univ of Miami / Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

Johns Hopkins Hosp; 🇺🇸 Baltimore, Maryland, United States

Univ of Texas Galveston; 🇺🇸 Galveston, Texas, United States

Charity Hosp / Tulane Univ Med School; 🇺🇸 New Orleans, Louisiana, United States

Northwestern Univ / SOCA; 🇺🇸 Chicago, Illinois, United States

Univ of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Emory Eye Clinic; 🇺🇸 Atlanta, Georgia, United States