Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000964
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
The Effect of Stomach Acid on Foscarnet
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Effect of Increasing Gastric pH Upon the Bioavailability of Orally Administered Phosphonoformic Acid Foscarnet
Status:
COMPLETED
Status Verified Date:
2021-10
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 see if ranitidine by reducing stomach acidity can enhance the effectiveness of foscarnet by making foscarnet more available to the body
Foscarnet is an antiviral compound Laboratory studies have shown it to be active against HIV However only 12 - 22 percent of an oral foscarnet dose is absorbed by the body Ranitidine suppresses gastric acid output increasing gastric pH Thus by increasing gastric pH decreasing stomach acidity less foscarnet is expected to be decomposed or broken down in the stomach Thus more foscarnet should be absorbed into the body
Foscarnet is an antiviral compound Laboratory studies have shown it to be active against HIV However only 12 - 22 percent of an oral foscarnet dose is absorbed by the body Ranitidine suppresses gastric acid output increasing gastric pH Thus by increasing gastric pH decreasing stomach acidity less foscarnet is expected to be decomposed or broken down in the stomach Thus more foscarnet should be absorbed into the body
Detailed Description:
Foscarnet is an antiviral compound Laboratory studies have shown it to be active against HIV However only 12 - 22 percent of an oral foscarnet dose is absorbed by the body Ranitidine suppresses gastric acid output increasing gastric pH Thus by increasing gastric pH decreasing stomach acidity less foscarnet is expected to be decomposed or broken down in the stomach Thus more foscarnet should be absorbed into the body
Six asymptomatic HIV-infected males or those with limited symptoms of early AIDS-related complex ARC will receive one dose intravenously of ranitidine in distilled water and one dose of placebo distilled water alone followed in 1 hour by foscarnet in oral solution The order of ranitidine and placebo is randomized and the two foscarnet doses are separated by at least 72 hours A nasogastric pH probe is placed on each morning of drug administration to monitor gastric pH
Six asymptomatic HIV-infected males or those with limited symptoms of early AIDS-related complex ARC will receive one dose intravenously of ranitidine in distilled water and one dose of placebo distilled water alone followed in 1 hour by foscarnet in oral solution The order of ranitidine and placebo is randomized and the two foscarnet doses are separated by at least 72 hours A nasogastric pH probe is placed on each morning of drug administration to monitor gastric pH
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 |
|---|---|---|---|
| 11111 | REGISTRY | DAIDS ES Registry Number | None |