Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety