Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy
Data Collection
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
It is hypothesized that the maximum AZT antiretroviral effect, which occurs at 8 weeks of therapy, will be enhanced by 2 weeks of foscarnet treatment, given at the same time by intermittent intravenous infusion. In addition, the further lowering of serum p24 antigen concentration that should occur during combined therapy might continue when oral AZT therapy is continued without foscarnet. There is a 4-week prestudy monitoring period during which AZT alone is administered on an outpatient basis, followed by a 2-week study period during which both intravenous foscarnet and oral AZT are administered in the hospital. During the subsequent 6-month follow-up period, oral AZT is administered and patients receive clinical evaluations. AZT is held for 48 hours on days before hospitalization and for 24 hours at the end of the hospitalization.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 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: Medication necessary for the patient's welfare at the discretion of the investigator. Patients must have the following: * Received zidovudine (AZT) 200 mg every 4 hours (q4h) continuously for 8 - 16 weeks without Grade 3 or higher toxicity. * Detectable p24 antigen in serum on at least 2 occasions during the prestudy period. All serum p24 antigen concentrations measured during the prestudy period must be at least twice the concentration cutoff value of the assay. * Capability of giving informed consent. * Per amendment of 890721, patients must enter the study period by September 30, 1989. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: * A history of hypersensitivity reaction to foscarnet or zidovudine (AZT). * History of Grade 3 or 4 toxicity with AZT. * Current Grade 2 or higher AZT toxicity. * Osteomalacia, neoplasm metastatic to bone, or other known bone disease. * Active opportunistic infection requiring myelosuppressive or nephrotoxic therapy. Concurrent Medication: Excluded: * Antimetabolites. * Immunomodulators. * Nephrotoxins. * Antiviral therapy. * Myelosuppressive or nephrotoxic therapy. * Acetaminophen. Patients with the following will be excluded: * A history of hypersensitivity reaction to foscarnet or zidovudine (AZT). * History of Grade 3 or 4 toxicity with AZT. * Current Grade 2 or higher AZT toxicity. * Osteomalacia, neoplasm metastatic to bone, or other known bone disease. * Active opportunistic infection requiring myelosuppressive or nephrotoxic therapy.
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 2 locations
University of Minnesota, ACTU
Minneapolis, United StatesOpen University of Minnesota, ACTU in Google MapsUnc Aids Crs
Chapel Hill, United States