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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001002
  Purpose

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 Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Foscarnet sodium
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Foscarnet    Foscarnet sodium    Fosfonet sodium    Phosphonoacetic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   12

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001002

Locations
United States, California
San Francisco AIDS Clinic / San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
USC School of Medicine / Norris Cancer Hosp    
      Los Angeles, California, United States, 90033
United States, North Carolina
Univ of North Carolina    
      Chapel Hill, North Carolina, United States, 275997215

Sponsors and Collaborators

Investigators
Study Chair:     Jacobson MA    
  More Information


Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   ACTG 053
First Received:   November 2, 1999
Last Updated:   July 11, 2008
ClinicalTrials.gov Identifier:   NCT00001002
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination  
Foscarnet  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex
Antiviral Agents
Zidovudine

Study placed in the following topic categories:
Virus Diseases
Phosphonoacetic Acid
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Foscarnet
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 31, 2008




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