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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01875952
Other study ID # Informed Consent:552 / 306
Secondary ID 000000000014520
Status Active, not recruiting
Phase Phase 4
First received March 28, 2012
Last updated June 11, 2013
Start date May 2010
Est. completion date June 2013

Study information

Verified date June 2013
Source Instituto Nacional de Salud Publica, Mexico
Contact n/a
Is FDA regulated No
Health authority Mexico: National Institute of Public Health, Health Secretariat
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine of once identified to the subjects infected with human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat her with isoniazid for six months, measuring the production of Interferon range pre and posttreatment, to evaluate this way the result of the treatment on the immune response


Description:

A descriptive analysis of the data will be made. Means and standard deviations for continuous data frequencies for categorical data will be performed. Wilcoxon test Mann-Whitney U test Chi square will be used for frequency analysis of responders Data Analysis and Statistical Software(STATA).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date June 2013
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Accept to participate. Informed consent.

- Human Immunodeficiency Virus positive test, documented by Western Blot

- Have not received treatment for latent tuberculosis

- Have not been diagnosed pulmonary tuberculosis (Tbp)

- Normal two chest X-rays, Postern-anterior and left lateral.

Exclusion Criteria:

- Active tuberculosis

- Previous diagnosis of tuberculosis

- Antecedent of treatment for active o latent tuberculosis

- Contact with TB patient harboring Multidrug resistance or isoniazid resistant isolates of Mycobacterium tuberculosis.

- Abnormal liver enzyme levels

- Hemoglobin below 8 gr/dl

- Allergy or intolerance to isoniazid

- Peripheral neuropathy

- Ingestion of drugs interacting with isoniazid

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Isoniazid
Isoniazid, 10 mg/Kg/day, no more than 300 mg/day, for six months

Locations

Country Name City State
Mexico Instituto Nacional de Salud Publica Mexico Cuernavaca Morelos
Mexico Clínica Especializada CONDESA Mexico City D.F

Sponsors (3)

Lead Sponsor Collaborator
Instituto Nacional de Salud Publica, Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Production of interferon gamma, in response to treatment of latent infection Before and after treatment intake Yes
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