A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

Phase 3

Completed

• Conditions: Cytomegalovirus Retinitis; HIV Infections

• Registration Number: NCT00000698
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To determine the safety and effectiveness of intravenous ganciclovir (also known as DHPG) in the treatment of sight-threatening cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of CMV retinitis.

Detailed Description

CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of CMV retinitis.

Patients are given GCV intravenously for 14 days. Then the patient receives the same dose, but only once a day, for as long as therapy is tolerated. If the retinitis worsens during the maintenance phase, the patient may again be given GCV for 14 days. Long-term treatment with GCV usually requires the surgical placement of a catheter in a large central vein in the chest or groin that is left in place indefinitely. If this is required, the procedure will be explained to the patient.

Study Timeline

• Status Verified: 1992-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Study Completion: 2007-08
• Last Update Submitted: 2008-09-26
• Last Update Posted: 2008-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Natl Inst of Allergy & Infect Dis / Cln Ctr; 🇺🇸 Bethesda, Maryland, United States