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NCT00002122 · ClinicalTrials.gov registry record · Phase 3

A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
720
Enrollment target

NCT00002122 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 720 participants.

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The verdict

NCT00002122, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
720 participants
Enrollment target

Study Summary

PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population. SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.

Interventions

  • DRUG Azithromycin
  • DRUG Fluconazole
  • DRUG Rifabutin

Trial Details

FieldValue
Enrollment Target 720 participants
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT00002122

The ClinicalTrials.gov registry entry for NCT00002122 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Azithromycin is the first listed.

NCT00002122 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00002122 about?

NCT00002122 is a clinical study titled "A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients". PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections...

What is the current status of trial NCT00002122?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 720 participants.

What interventions are being tested in trial NCT00002122?

The interventions under investigation include: Azithromycin (DRUG), Fluconazole (DRUG), Rifabutin (DRUG).

Who is sponsoring clinical trial NCT00002122?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.