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

NCT ID: NCT01875952

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-06-30

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).

Conditions

Human Immunodeficiency Virus (HIV); Tuberculosis (TB); Latent Tuberculosis Infection (LTI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

one arm

All patients with response to positive purified protein derivative (PPD) test are treated

Group Type: OTHER

Isoniazid

Intervention Type: DRUG

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

Interventions

Isoniazid

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Enfermedades Respiratorias

OTHER_GOV

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: collaborator

Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role: lead

Responsible Party

Ma. de Lourdes Garcia Garcia

Director of the Center of Research in Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Sifuentes, Doctor

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nitrición Salvador Zubiran (INCMNSZ)

Alfredo Ponce-de-León, Doctor

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutrición (INCMNSZ)

Maria de Lourdes García-García, Post doctor

Role: STUDY_DIRECTOR

Instituto Nacional de Salud Publica (INSP)

Jose Luis Valdespino-Gómez, MD

Role: PRINCIPAL_INVESTIGATOR

Laboratorios Nacionales de Biológicos y Reactrivos (BIRMEX)

Martha Torres Rojas, Post Doctor

Role: STUDY_CHAIR

National Institute of Respiratory Diseases (INER)

Locations

Instituto Nacional de Salud Publica

México, Cuernavaca Morelos, Mexico

Clínica Especializada CONDESA

Mexico City, D.F, Mexico

Countries

Mexico

Other Identifiers

000000000014520

Identifier Type: OTHER

Identifier Source: secondary_id

Informed Consent:552 / 306

Identifier Type: -

Identifier Source: org_study_id