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:
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
  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: Open Label
Primary Purpose: Treatment
Official Title: Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy

Resource links provided by NLM:


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

Estimated 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

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
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
Investigators
Study Chair: Jacobson MA
  More Information

Additional Information:
Publications:
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
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Foscarnet
Phosphonoacetic Acid
Zidovudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antimetabolites
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 21, 2014