Clinical trial NCT01875952: Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL)
Official title: Integral Research of the Managing and Treatment of the Infection With Human Immunodeficiency (VIH) /Human Immunodeficiency Syndrome(SIDA) Co-infection With Latent Tuberculosis Infection. A Multidisciplinary and Interinstitucional Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Human Immunodeficiency Virus (HIV)
Tuberculosis (TB)
Latent Tuberculosis Infection (LTI)
Keywords: Latent tuberculosis infection
Human immunodeficiency virus (HIV)
Treatment
Isoniazid
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Enfermedades Respiratorias
name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
First posted: 2013-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Production of interferon gamma, in response to treatment of latent infection
timeFrame: Before and after treatment intake
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Salud Publica
state: Cuernavaca Morelos
city: Mexico City
country: Mexico
facility: Clínica Especializada CONDESA
state: D.F
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nitrición Salvador Zubiran (INCMNSZ)
name: José Sifuentes, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición (INCMNSZ)
name: Alfredo Ponce-de-León, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Salud Publica (INSP)
name: Maria de Lourdes García-García, Post doctor
role: STUDY_DIRECTOR
affiliation: Laboratorios Nacionales de Biológicos y Reactrivos (BIRMEX)
name: Jose Luis Valdespino-Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Respiratory Diseases (INER)
name: Martha Torres Rojas, Post Doctor
role: STUDY_CHAIR
References: