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
Completed · Phase 4
Conditions studied: Cytomegalovirus Infections, HIV Infections, Hypocalcemia
In brief
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.
Key facts
- Study ID
- NCT00002146
- Run by
- Astra USA
- People needed
- 12
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Oklahoma City Veterans Administration Med Ctr — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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