The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

Phase 2

Completed

• Conditions: Gastrointestinal Diseases; Cytomegalovirus Retinitis; HIV Infections

• Registration Number: NCT00001034
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression.

The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.

Detailed Description

The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.

Patients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDMENT 5/2/95: After the common closing date (6/3/95) patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 8/31/95.

Study Timeline

• Study Completion: 1995-08
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (17)

Community Consortium of San Francisco; 🇺🇸 San Francisco, California, United States

Denver CPCRA / Denver Public Hlth; 🇺🇸 Denver, Colorado, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med; 🇺🇸 New Orleans, Louisiana, United States

Veterans Administration Med Ctr / Regional AIDS Program; 🇺🇸 Washington, District of Columbia, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Comprehensive AIDS Alliance of Detroit; 🇺🇸 Detroit, Michigan, United States

Schering - Plough Corp; 🇺🇸 Kenilworth, New Jersey, United States

Henry Ford Hosp; 🇺🇸 Detroit, Michigan, United States

Clinical Directors Network of Region II; 🇺🇸 New York, New York, United States

Bronx Lebanon Hosp Ctr; 🇺🇸 Bronx, New York, United States

Addiction Research and Treatment Corp; 🇺🇸 Brooklyn, New York, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr; 🇺🇸 New York, New York, United States

Richmond AIDS Consortium; 🇺🇸 Richmond, Virginia, United States

AIDS Research Alliance - Chicago; 🇺🇸 Chicago, Illinois, United States

Wilmington Hosp / Med Ctr of Delaware; 🇺🇸 Wilmington, Delaware, United States

North Jersey Community Research Initiative; 🇺🇸 Newark, New Jersey, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp; 🇺🇸 Portland, Oregon, United States