- Multiple Sclerosis
- Gastrointestinal Diseases
- Diabetic Neuropathies
- Hepatitis, Chronic
- Retinal Diseases
- Waldenstrom Macroglobulinemia
- Eating Disorders
- Deglutition Disorders
- Neck Pain
- Neoplasms, Second Primary
- Carcinomatous Meningitis
- Uterine Cervical Neoplasms
- Pleural Effusion
- Muscular Dystrophy, Duchenne
- Movement Disorders
- Leukemia, Hairy Cell
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
Study Design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
Phase: Phase 4
Trial Identifier: NCT00002146
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
Description: 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.
+ Additional Objectives Detail
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:Accepts Healthy Volunteers?: No
Minimum Age: 18 Years
Maximum Age: N/A
Additional 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.
Acquired Immunodeficiency Syndrome
Drug: Magnesium sulfate
Drug: Foscarnet sodium
Location & Contacts:
+ Show All 1 Study Locations
United States, Oklahoma
Oklahoma City Veterans Administration Med Ctr
Oklahoma City, Oklahoma, United States
There are a number of clinical trials underway to find effective treatments for diabetes, including new drugs, surgery and even transplantation.
There are several current and ongoing trials of interventions for major depressive disorder, which is characterized by a disabling combination of symptoms causing severe disruption to the sufferer's ability to carry out routine functions and tasks of daily life.
Constipation is a illness where the bowels cannot move waste material out of the body in a normal manner. There are various clinical trials recruiting participants to study the effectiveness of various treatments.