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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002146
• Other study ID #: 020J
• Secondary ID: 94-FOS-32
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• HIV Infections
• Hypocalcemia
• Infection

Intervention

Drug:
• Magnesium sulfate

• Foscarnet sodium

Locations

Country	Name	City	State
United States	Oklahoma City Veterans Administration Med Ctr	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Astra USA

Country where clinical trial is conducted

United States,