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NCT00000638 · ClinicalTrials.gov registry record · NA
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 2,000
- Enrollment target
NCT00000638 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2,000 participants.
The verdict
NCT00000638, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 2,000 participants
- Enrollment target
Study Summary
To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
Interventions
- DRUG Rifampin
- DRUG Pyrazinamide
- DRUG Isoniazid
- DRUG Pyridoxine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Est. Completion | 1999-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000638
The ClinicalTrials.gov registry entry for NCT00000638 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Rifampin is the first listed.
NCT00000638 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000638 about?
NCT00000638 is a clinical study titled "Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection". To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidel...
What is the current status of trial NCT00000638?
This trial is currently completed. It is a NA study. The enrollment target is 2,000 participants. Estimated completion is 1999-09.
What interventions are being tested in trial NCT00000638?
The interventions under investigation include: Rifampin (DRUG), Pyrazinamide (DRUG), Isoniazid (DRUG), Pyridoxine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00000638?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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