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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|ClinicalTrials.gov Identifier: NCT00002146|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections HIV Infections Hypocalcemia||Drug: Magnesium sulfate Drug: Foscarnet sodium||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|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|
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002146
|United States, Oklahoma|
|Oklahoma City Veterans Administration Med Ctr|
|Oklahoma City, Oklahoma, United States, 731045028|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||January 1997|
Acquired Immunodeficiency Syndrome
DNA Virus Infections
Calcium Metabolism Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Reproductive Control Agents