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

NCT00002146 | Completed Phase 4

• 2 other identifiers: 020J94-FOS-32
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections; HIV Infections; Hypocalcemia

Keywords

Infusions, Intravenous; Foscarnet; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Magnesium Sulfate; Magnesium Deficiency; Hypocalcemia

Interventions

Magnesium sulfate DRUG

Foscarnet sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astra USA: lead

Study Sites (1)

Oklahoma City Veterans Administration Med Ctr

Oklahoma City, Oklahoma, 731045028, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; HIV Infections; Hypocalcemia; Acquired Immunodeficiency Syndrome; Magnesium Deficiency

Interventions

Magnesium Sulfate; Foscarnet

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Slow Virus Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1997-01

Locations

US (1)