HIV Infections Clinical Trial
Official title:
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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