A Randomized, Comparative, Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus (CMV) Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression
Ganciclovir
Blood-Borne Infections+32
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.850 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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 13 Years
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: Antiretroviral therapy. Anti-PCP prophylaxis. Maintenance or prophylaxis therapy for other opportunistic infections besides CMV. Patients must have: Working diagnosis of HIV infection. CD4 count <= 100 cells/mm3. Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry. Reasonably good health. Life expectancy of at least 6 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute life-threatening illness. Active lymphoma. Hypersensitivity to acyclovir. Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements. Concurrent Medication: Excluded: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Foscarnet. Intravenous ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity. Prior Medication: Excluded within 60 days prior to study entry: Foscarnet. Excluded within 2 weeks prior to study entry: Vidarabine. Amantadine hydrochloride (Symmetrel). CMV hyperimmune globulin/intravenous immune globulin. Cytarabine. Fiacitabine (FIAC) or fialuridine (FIAU). Ganciclovir. HPMPC. Idoxuridine. Intravenous acyclovir. Oral acyclovir at > 1 g/day. Other drugs with potential anti-CMV activity.
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 17 locations
Community Consortium of San Francisco
San Francisco, United StatesOpen Community Consortium of San Francisco in Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesWilmington Hosp / Med Ctr of Delaware
Wilmington, United StatesVeterans Administration Med Ctr / Regional AIDS Program
Washington D.C., United States