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

Human Immunodeficiency Virus (HIV) Clinical Trial

— HIV/TB  

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

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

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes
• Infection
• Latent Tuberculosis
• Latent Tuberculosis Infection (LTI)
• Tuberculosis
• Tuberculosis (TB)

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