Viewing Study NCT00000826



Ignite Creation Date: 2024-05-05 @ 10:00 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00000826
Status: COMPLETED
Last Update Posted: 2021-10-29
First Post: 1999-11-02

Brief Title: Effect of Fluconazole Clarithromycin and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Effect of Fluconazole Clarithromycin and Rifabutin on the Pharmacokinetics of Sulfamethoxazole and Dapsone and Their Hydroxylamine Metabolites
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 determine the effects of fluconazole and either rifabutin or clarithromycin alone and in combination on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in HIV-infected patients

Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease little is known about possible adverse drug interactions The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed
Detailed Description: Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease little is known about possible adverse drug interactions The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed

In Part A patients receive sulfamethoxazole-trimethoprim SMXTMP alone for 2 weeks then in combination with fluconazole rifabutin or both drugs each over 2-week periods in a randomly assigned order Patients in Part B receive the same regimens except with clarithromycin substituted for rifabutin In Part C patients receive dapsone alone for 2 weeks then in combination with fluconazole rifabutin or both drugs in the same manner as in Part A Part D patients receive the same regimen as those in Part C except with clarithromycin substituted for rifabutin Patients are followed every 2 weeks

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
11259 REGISTRY DAIDS ES Registry Number None