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 on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Calcium Cytomegalovirus Infections HIV/AIDS

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

U.S. FDA Resources

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

ClinicalTrials.gov 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
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Magnesium Sulfate
Magnesium Deficiency
Hypocalcemia

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
Hypocalcemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections

Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Foscarnet
Phosphonoacetic Acid
Magnesium Sulfate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on February 09, 2012