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 - Full Text View

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.

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 Cytomegalovirus Infections

ChemIDplus related topics:

Magnesium Magnesium sulfate Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid

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

Study ID Numbers:	020J, 94-FOS-32
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002146
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:

Phosphonoacetic Acid

Hypocalcemia

Sexually Transmitted Diseases, Viral

Metabolic Diseases

Magnesium Sulfate

Acquired Immunodeficiency Syndrome

Cytomegalovirus

Immunologic Deficiency Syndromes

Herpesviridae Infections

Virus Diseases

HIV Infections

Sexually Transmitted Diseases

Cytomegalovirus Infections

DNA Virus Infections

Water-Electrolyte Imbalance

Foscarnet

Metabolic disorder

Cytomegalic inclusion disease

Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents

Communicable Diseases

Slow Virus Diseases

Molecular Mechanisms of Pharmacological Action

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

Analgesics

Anti-Arrhythmia Agents

Nucleic Acid Synthesis Inhibitors

RNA Virus Infections

Immune System Diseases

Central Nervous System Depressants

Enzyme Inhibitors

Cardiovascular Agents

Antiviral Agents

Pharmacologic Actions

Lentivirus Infections

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on September 05, 2008