Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL)

Phase 4

• Conditions: Human Immunodeficiency Virus (HIV); Tuberculosis (TB); Latent Tuberculosis Infection (LTI)
• Interventions: Drug: Isoniazid

• Registration Number: NCT01875952
• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico

Brief 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

Detailed 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).

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-03-28
• Primary Completion: 2012-06
• Status Verified: 2013-06
• Study Completion: 2013-06
• Study First Submitted QC: 2013-06-11
• Last Update Submitted: 2013-06-11
• Study First Posted: 2013-06-12
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one arm	Isoniazid	All patients with response to positive purified protein derivative (PPD) test are treated

Primary Outcome Measures

Name	Time	Method
Production of interferon gamma, in response to treatment of latent infection	Before and after treatment intake

Trial Locations

Locations (2)

Instituto Nacional de Salud Publica; 🇲🇽 Mexico, Cuernavaca Morelos, Mexico

Clínica Especializada CONDESA; 🇲🇽 Mexico City, D.F, Mexico