Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection
Data Collection
Blood-Borne Infections+26
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Because recent information has shown AZT to be useful in treating AIDS, it is assumed that most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT. Because AZT is reported not to be active against cytomegalovirus (CMV), it is important to see if it is useful to give GCV along with AZT. Patients are placed into one of four groups at entry into study according to their previous treatment: I: Prior treatment with AZT up to the time of developing CMV infection and not requiring dose reduction of AZT for toxicity. II: Prior treatment with AZT up to the time of developing CMV infection and requiring dose reduction of AZT for toxicity. III: Prior therapy with GCV for CMV infection. These patients should already be in the maintenance phase, having completed a minimum of 2 weeks of induction therapy. IV: No prior therapy with either AZT or GCV. Treatment lasts 24 weeks and consists of two treatment plans: A: Patients not previously treated with GCV are started on GCV for an additional 22 weeks. GCV is given as a 1-hour infusion. All patients are started on AZT at the lowest dose. B: For patients with chronic CMV disease who are receiving GCV maintenance, GCV is administered as a 1-hour infusion 5 days/week. AZT is added and treatment with GCV is standardized prior to beginning of the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 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 18 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: * Symptomatic therapy such as analgesics, antihistamines, antiemetics, and antidiarrheal agents, or other supportive therapy may be administered as deemed necessary by the responsible investigator. For fever, the following regimens should be used: * If fever above 39.0 degrees C, antipyretic therapy will be administered employing aspirin, 650 mg orally every 4 hours x 3 doses, or until fever falls below 39.0 degrees C. * If fever of higher than 39.0 degrees C occurs for 2 consecutive days, the patient may be premedicated with aspirin. Exclusion Criteria * Active alcohol or drug abuse. Co-existing Condition: Excluded: * Patients with other life-threatening and uncontrolled opportunistic infections on enrollment. Patients with the following prior conditions are excluded if they: * Have other life-threatening and uncontrolled opportunistic infections on enrollment. Prior Medication: Excluded within 1 week of study entry: * Systemic therapy with antimetabolite. * Cytotoxic drug. * Interferon. * Immunologic modulators. * Corticosteroids. * Nucleoside analogs other than zidovudine (AZT). * Excluded within 2 weeks of study entry: * Therapy for any other opportunistic infections. * Excluded within 2 months of study entry: * Ribavirin. Prior Treatment: Excluded within 2 weeks of study entry (for treatment group I): * Blood transfusion. * Excluded within 1 month of study entry (for treatment groups II and III): * Blood transfusion. All patients must be: * Able to provide informed consent. * Likely to be available for follow-up for at least 4 months.
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 3 locations
Univ of California / San Diego Treatment Ctr
San Diego, United StatesOpen Univ of California / San Diego Treatment Ctr in Google MapsBellevue Hosp / New York Univ Med Ctr
New York, United StatesUniv of Rochester Medical Center
Rochester, United States