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Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002146
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
To determine whether acute ionized hypomagnesemia and hypocalcemia immediately following foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. To determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. To evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by monitoring blood pressure, heart rate, and heart rhythm. To characterize the effect of magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium, phosphate, and foscarnet.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections HIV Infections Hypocalcemia Drug: Magnesium sulfate Drug: Foscarnet sodium Phase 4

Detailed Description:
Patients are randomized to one of four treatment groups. Intravenous foscarnet is administered for 4 days. Patients receive one of three doses of magnesium sulfate or placebo in normal saline according to one of four schedules. Sequence of doses will differ for each group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • AIDS by CDC criteria.
  • Documented CMV disease.
  • Tolerance of foscarnet dose of 90 mg/kg bid.
  • Normal serum calcium, serum creatinine, and serum phosphate.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known allergy to Foscarnet.
  • In extremis or incapacitated because of underlying illness (e.g., comatose or tracheally intubated).
  • Volume depletion.

Concurrent Medication:

Excluded:

  • Nephrotoxic drugs such as IV pentamidine, amphotericin B, aminoglycosides, and cisplatin.
  • Other investigational drugs that affect metabolic balance, such as human growth hormone.
  • Oral or parenteral magnesium and calcium supplementation.

Patients with the following prior condition are excluded:

History of heart block.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002146


Locations
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United States, Oklahoma
Oklahoma City Veterans Administration Med Ctr
Oklahoma City, Oklahoma, United States, 731045028
Sponsors and Collaborators
Astra USA
More Information
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ClinicalTrials.gov Identifier: NCT00002146    
Other Study ID Numbers: 020J
94-FOS-32
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1997
Keywords provided by NIH AIDS Clinical Trials Information Service:
Infusions, Intravenous
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
 Magnesium Sulfate
Magnesium Deficiency
Hypocalcemia
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Cytomegalovirus Infections
Hypocalcemia
Disease Attributes
Pathologic Processes
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Foscarnet
Phosphonoacetic Acid
Magnesium Sulfate
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Antiviral Agents