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A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001002
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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) patients who have already received AZT for 8 - 52 weeks.

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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Zidovudine Drug: Foscarnet sodium Phase 1

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy
Actual Study Completion Date : June 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001002


Locations
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United States, Minnesota
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Jacobson MA
More Information
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Publications:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001002    
Other Study ID Numbers: ACTG 053
11027 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: October 2021
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Foscarnet
Acquired Immunodeficiency Syndrome
 AIDS-Related Complex
Antiviral Agents
Zidovudine
Additional relevant MeSH terms:
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Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Zidovudine
Foscarnet
Phosphonoacetic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents