Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000959
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Prophylaxis Against Tuberculosis TB in Patients With Human Immunodeficiency Virus HIV Infection and Suspected Latent Tuberculous Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Prophylaxis Against Tuberculosis TB in Patients With Human Immunodeficiency Virus HIV Infection and Suspected Latent Tuberculous Infection
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 evaluate the safety and effectiveness of a 6-month course of isoniazid INH in the prevention of clinical tuberculosis in anergic having diminished or absent reactions to specific antigens HIV-infected persons who are at high risk for tuberculous infection
A substantial number of HIV-infected persons are anergic and thus do not respond to the only currently available diagnostic tool for tuberculosis infection that is the PPD purified protein derivative skin test Many of these anergic persons are however infected with Mycobacterium tuberculosis and eventually develop reactivation tuberculosis causing both individual illness and spread of infection to others in the community This study examines the possibility of using INH prophylaxis that is for prevention in anergic HIV-infected patients at high risk for tuberculosis as a means of decreasing the sharp rise in the incidence of tuberculosis due to HIV infection INH is inexpensive and relatively safe and thus may demonstrate an acceptable riskbenefit ratio as a medication that can be given over a limited period of time to a population suspected of having but not proved to have M tuberculosis infection If this study shows INH to be safe and effective in this setting it could have a major effect on public health in this country
A substantial number of HIV-infected persons are anergic and thus do not respond to the only currently available diagnostic tool for tuberculosis infection that is the PPD purified protein derivative skin test Many of these anergic persons are however infected with Mycobacterium tuberculosis and eventually develop reactivation tuberculosis causing both individual illness and spread of infection to others in the community This study examines the possibility of using INH prophylaxis that is for prevention in anergic HIV-infected patients at high risk for tuberculosis as a means of decreasing the sharp rise in the incidence of tuberculosis due to HIV infection INH is inexpensive and relatively safe and thus may demonstrate an acceptable riskbenefit ratio as a medication that can be given over a limited period of time to a population suspected of having but not proved to have M tuberculosis infection If this study shows INH to be safe and effective in this setting it could have a major effect on public health in this country
Detailed Description:
A substantial number of HIV-infected persons are anergic and thus do not respond to the only currently available diagnostic tool for tuberculosis infection that is the PPD purified protein derivative skin test Many of these anergic persons are however infected with Mycobacterium tuberculosis and eventually develop reactivation tuberculosis causing both individual illness and spread of infection to others in the community This study examines the possibility of using INH prophylaxis that is for prevention in anergic HIV-infected patients at high risk for tuberculosis as a means of decreasing the sharp rise in the incidence of tuberculosis due to HIV infection INH is inexpensive and relatively safe and thus may demonstrate an acceptable riskbenefit ratio as a medication that can be given over a limited period of time to a population suspected of having but not proved to have M tuberculosis infection If this study shows INH to be safe and effective in this setting it could have a major effect on public health in this country
Patients are placed by a random selection process in either the INH or placebo group One group receives INH plus pyridoxine hydrochloride vitamin B6 daily for six months Patients in the other group receive placebo plus vitamin B6 daily for six months
Patients are placed by a random selection process in either the INH or placebo group One group receives INH plus pyridoxine hydrochloride vitamin B6 daily for six months Patients in the other group receive placebo plus vitamin B6 daily for six months
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 |
|---|---|---|---|
| 11557 | REGISTRY | DAIDS ES Registry Number | None |