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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Astra USA
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002146

Purpose

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 Hypocalcemia	Drug: Magnesium sulfate Drug: Foscarnet sodium	Phase IV

MedlinePlus related topics: AIDS Calcium Cytomegalovirus Infections

Drug Information available for: Magnesium sulfate Fosfonet sodium Foscarnet sodium Phosphonoacetic acid Foscarnet Magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
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

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

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002146

Locations

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

Study ID Numbers:	020J, 94-FOS-32
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002146 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Infusions, Intravenous
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Magnesium Sulfate
Magnesium Deficiency
Hypocalcemia

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Phosphonoacetic Acid
Magnesium Sulfate
Calcium Channel Blockers
Anesthetics
Cytomegalovirus
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Cytomegalic Inclusion Disease
Cytomegalovirus Infections
Water-Electrolyte Imbalance
Anti-Arrhythmia Agents
Analgesics
Retroviridae Infections
Metabolic Disorder

Hypocalcemia
Metabolic Diseases
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Cardiovascular Agents
Antiviral Agents
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Calcium, Dietary
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Foscarnet
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Phosphonoacetic Acid
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Magnesium Sulfate
Physiological Effects of Drugs
Calcium Channel Blockers
Anesthetics
Reproductive Control Agents
Infection
Reverse Transcriptase Inhibitors
Membrane Transport Modulators
Calcium Metabolism Disorders

Tocolytic Agents
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses
Cytomegalovirus Infections
Water-Electrolyte Imbalance
Anti-Arrhythmia Agents
Analgesics
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Hypocalcemia
Metabolic Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on May 07, 2009