A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease
Foscarnet sodium
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS. Patients are divided into three groups: (1) asymptomatic patients with or without persistent generalized lymphadenopathy (PGL) syndrome; (2) patients with AIDS; and (3) patients who have or have had mild to moderate signs or symptoms consistent with HIV infection. Patients are then randomly chosen to receive one of three different foscarnet doses. The drug is given for 4 weeks, by 1-hour infusion administered every 8 hours. In addition, those patients who are clinically stable and have not experienced severe toxicity at the end of the 4 weeks may continue treatment, in the form of a single daily dose of foscarnet to be administered 5 days per week. Blood samples are taken during treatment and at the first, fourth, and eighth week after treatment. If the patient is on maintenance, blood samples are taken weekly. Effective 7-17-89, patients entering the study are assigned to the lowest foscarnet dose. Patients receive daily treatment for 28 days. Patients who are clinically stable without severe toxicity at 4 weeks have the option of maintenance therapy with foscarnet.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 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: Aerosolized pentamidine for secondary Pneumocystis carinii pneumonia (PCP) prophylaxis. Short course therapy with oral acyclovir (ACV) = or < 7 days. Short course therapy with ketoconazole = or < 7 days for patients who are not responding to any other therapy. Flurazepam. Diphenhydramine. Prior Medication: Allowed: Systemic therapy, prophylaxis or maintenance for an AIDS-defining opportunistic infection. Patients with any of the following findings may be included: Asymptomatic HIV patients with or without lymphadenopathy. Patients with AIDS as defined by the CDC surveillance case definitions. Patients with past or present mild to moderate signs or symptoms consistent with HIV infection. p24 antigen in the serum = or > 60 pg/ml. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. Cytomegalovirus (CMV) retinitis. AIDS dementia. Concurrent Medication: Excluded: Antiretrovirals. Immunomodulatory agents. Corticosteroids Other systemic antiviral or antimicrobial agents. Experimental medications. Excluded on chronic basis and discouraged for > 72 hours: Acetaminophen. Narcotics. Aspirin. Concurrent Treatment: Excluded: Transfusion dependency or requirement of 2 units of blood more than once per month. Patients with the following will be excluded: Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. Cytomegalovirus (CMV) retinitis. AIDS dementia. Prior Medication: Excluded within 30 days of study entry: Antiretroviral agents (except ribavirin). Immunomodulatory agents. Excluded within 60 days of study entry: Ribavirin. The last blood transfusion cannot have been given within 2 weeks of entry. Active substance abuse which could impair compliance with the protocol.
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 11 locations
Los Angeles County - USC Med Ctr
Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google MapsUSC School of Medicine / Norris Cancer Hosp
Los Angeles, United StatesUniv of California / San Diego Treatment Ctr
San Diego, United StatesUniv of Minnesota
Minneapolis, United States