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

NCT00001002 | Completed Phase 1

• 2 other identifiers: ACTG 05311027
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; Foscarnet; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents; Zidovudine

Interventions

Zidovudine DRUG

Foscarnet sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• Jacobsen MA, van der Horst C, Causey DM, Dehlinger M, Hafner R, Mills J. In vivo additive antiretroviral effect of combined zidovudine and foscarnet therapy for human immunodeficiency virus infection (ACTG Protocol 053). J Infect Dis. 1991 Jun;163(6):1219-22. doi: 10.1093/infdis/163.6.1219.

  PMID: 1828075 BACKGROUND

• Aweeka FT, Gambertoglio JG, van der Horst C, Raasch R, Jacobson MA. Pharmacokinetics of concomitantly administered foscarnet and zidovudine for treatment of human immunodeficiency virus infection (AIDS Clinical Trials Group protocol 053). Antimicrob Agents Chemother. 1992 Aug;36(8):1773-8. doi: 10.1128/AAC.36.8.1773.

  PMID: 1416864 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zidovudine; Foscarnet

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds

Study Officials

• Jacobson MA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 1991
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (2)