A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Ganciclovir
Blood-Borne Infections+32
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 3 Months
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, United StatesOpen Natl Inst of Allergy & Infect Dis / Cln Ctr in Google Maps