Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002146
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
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
Sponsor:
Astra USA
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
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
Status:
COMPLETED
Status Verified Date:
1997-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-FOS-32 | None | None | None |