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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Infections; HIV Infections; Hypocalcemia

Intervention: Magnesium sulfate (Drug); Foscarnet sodium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astra USA

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Oklahoma City Veterans Administration Med Ctr, Oklahoma City, Oklahoma 731045028, United States
Additional Information


Last updated: June 23, 2005

Page last updated: August 20, 2015

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