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

Launched by ASTRA USA · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.