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Clinical Trials

MainTitle

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
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00001002

First received: November 2, 1999
Last updated: March 28, 2012
Last Verified: March 2012
History of Changes
Purpose

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 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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):

Enrollment: 12
Study Completion Date: June 1991

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

Locations

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

Study Chair: Jacobson MA
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00001002   History of Changes  
Other Study ID Numbers: ACTG 053  
  11027  
Study First Received: November 2, 1999  
Last Updated: March 28, 2012  

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:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Zidovudine
Foscarnet
Phosphonoacetic Acid

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.