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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Foscarnet sodium
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Foscarnet, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota, ACTU
  • Unc Aids Crs

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001002
Brief Title
A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
Official Title
Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1991 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Foscarnet, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Foscarnet sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobson MA
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota, ACTU
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1828075
Citation
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.
Results Reference
background
PubMed Identifier
1416864
Citation
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.
Results Reference
background

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

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