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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1997
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 Intervention Phase
Cytomegalovirus Infections
HIV Infections
Drug: Magnesium sulfate
Drug: Foscarnet sodium
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 12
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:


  • 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.

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Please refer to this study by its identifier: NCT00002146

United States, Oklahoma
Oklahoma City Veterans Administration Med Ctr
Oklahoma City, Oklahoma, United States, 731045028
Sponsors and Collaborators
Astra USA
  More Information

No publications provided Identifier: NCT00002146     History of Changes
Other Study ID Numbers: 020J, 94-FOS-32
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Infusions, Intravenous
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Magnesium Sulfate
Magnesium Deficiency

Additional relevant MeSH terms:
Cytomegalovirus Infections
Calcium Metabolism Disorders
DNA Virus Infections
Herpesviridae Infections
Metabolic Diseases
Virus Diseases
Water-Electrolyte Imbalance
Magnesium Sulfate
Phosphonoacetic Acid
Anti-Arrhythmia Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents processed this record on November 25, 2015