Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00001002
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00001002
Study Brief:
Protocol Section:
NCT00001002