Status:
COMPLETED
A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To study the toxicity, pharmacokinetics, and antiretroviral effectiveness of combined oral zidovudine (AZT) and intermittent intravenous foscarnet therapy in stable AIDS or AIDS related complex (ARC) ...
Detailed Description
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 intravenou...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 1991
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00001002
End Date
June 1 1991
Last Update
November 4 2021
Active Locations (2)
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1
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455
2
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27599