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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cytomegalovirus Infections HIV Infections Hypocalcemia

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Magnesium sulfate

Intervention Type DRUG

Foscarnet sodium

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Oklahoma City Veterans Administration Med Ctr

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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94-FOS-32

Identifier Type: -

Identifier Source: secondary_id

020J