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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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002146
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002146 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Cytomegalovirus Infections
  • HIV Infections
  • Hypocalcemia
  • Drug: Magnesium sulfate
  • Drug: Foscarnet sodium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002146
020J, 94-FOS-32
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Astra USA
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NIH AIDS Clinical Trials Information Service
January 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP