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

Sponsor

Astra USA (Industry)

Overall Status

Completed

CT.gov ID

NCT00002146

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Infections HIV Infections Hypocalcemia	Drug: Magnesium sulfate Drug: Foscarnet sodium	Phase 4

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.

Study Design

Study Type:

Interventional

Masking:

Double

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.