Back to resultsSafety 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
Primary Purpose
Cytomegalovirus Infections, HIV Infections, Hypocalcemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Magnesium sulfate
Foscarnet sodium
Sponsored by
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring Infusions, Intravenous, Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Magnesium Sulfate, Magnesium Deficiency, Hypocalcemia
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.
Sites / Locations
- Oklahoma City Veterans Administration Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002146
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
January 1997
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Astra USA
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections, HIV Infections, Hypocalcemia
Keywords
Infusions, Intravenous, Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Magnesium Sulfate, Magnesium Deficiency, Hypocalcemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Double
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Type
Drug
Intervention Name(s)
Foscarnet sodium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Oklahoma City Veterans Administration Med Ctr
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
731045028
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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