A Treatment Protocol for the Use of Intravenous Ganciclovir NCT00000698

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00000698
Other study ID #	TX 303
Secondary ID
Status	Completed
Phase	Phase 3
First received	November 2, 1999
Last updated	September 26, 2008
Est. completion date	August 2007

Study information
Verified date	April 1992
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date	August 2007
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	3 Months and older
Eligibility	Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia. - Topical ophthalmics. - Topical acyclovir. Concurrent Treatment: Allowed: - Hemodialysis for patients with renal impairment. Patients must have: - Diagnosis of AIDS and immediately sight-threatening cytomegalovirus retinitis. Prior Medication: Allowed: - Zidovudine. - Prior therapy for retinitis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Non-immediately sight-threatening cytomegalovirus retinitis. Concurrent Medication: Excluded: - Systemic investigational agents such as antimetabolites, alkylating agents, nucleoside analogs, acyclovir sodium (Zovirax). - Interferon. - Cytokines. - Foscarnet (non-nucleoside pyrophosphate analog). - Ganciclovir may be withheld for up to 21 days for an acute course with an investigational or toxic therapy or oral / IV acyclovir. Patients with the following are excluded: - Non-immediately sight-threatening cytomegalovirus retinitis.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ganciclovir

Locations
Country	Name	City	State
United States	Natl Inst of Allergy & Infect Dis / Cln Ctr	Bethesda	Maryland

Sponsors *(1)*
Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,

References & Publications (1)

Feinberg J, Katz D, Mastre B, DeArmond B. Ganciclovir (GCV) in AIDS patients with immediately sight-threatening CMV retinitis (ISTCR): initial summary of "treatment IND" data. Int Conf AIDS. 1990 Jun 20-23;6(1):230 (abstract no ThB432)

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External Links

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

Clinical Trial Details — Status: Completed

Administrative data

Study information