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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oklahoma City Veterans Administration Med Ctr

Oklahoma City, Oklahoma, 731045028, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulfate

Drug

Foscarnet sodium

Drug

Sponsors and collaborators

Lead sponsor

Astra USA

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed