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

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

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

Study Overview

• Status: Unknown
• Conditions: Human Immunodeficiency Virus (HIV); Tuberculosis (TB); Latent Tuberculosis Infection (LTI)
• Intervention / Treatment: Drug: Isoniazid

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Cuernavaca Morelos
    • Mexico, Cuernavaca Morelos, Mexico, 62100
      • Instituto Nacional de Salud Publica
  • D.F
    • Mexico City, D.F, Mexico, 06140
      • Clínica Especializada CONDESA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: one arm; All patients with response to positive purified protein derivative (PPD) test are treated	Drug: Isoniazid; Isoniazid, 10 mg/Kg/day, no more than 300 mg/day, for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Production of interferon gamma, in response to treatment of latent infection	Before and after treatment intake

Collaborators and Investigators

• Sponsor: Instituto Nacional de Salud Publica, Mexico
• Collaborators: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Instituto Nacional de Enfermedades Respiratorias
• Investigators: Principal Investigator: José Sifuentes, Doctor, Instituto Nacional de Ciencias Medicas y Nitrición Salvador Zubiran (INCMNSZ); Principal Investigator: Alfredo Ponce-de-León, Doctor, Instituto Nacional de Ciencias Medicas y Nutrición (INCMNSZ); Study Director: Maria de Lourdes García-García, Post doctor, Instituto Nacional de Salud Pública (INSP); Principal Investigator: Jose Luis Valdespino-Gómez, MD, Laboratorios Nacionales de Biológicos y Reactrivos (BIRMEX); Study Chair: Martha Torres Rojas, Post Doctor, National Institute of Respiratory Diseases (INER)

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (Estimate): June 12, 2013

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 11, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Treatment; Isoniazid; Latent tuberculosis infection; Human immunodeficiency virus (HIV)
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Tuberculosis; Latent Tuberculosis; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Coinfection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Anti-Bacterial Agents; Antitubercular Agents; Fatty Acid Synthesis Inhibitors; Isoniazid
• Other Study ID Numbers: Informed Consent:552 / 306; 000000000014520 (Other Identifier: National Council for Science and Technology (CONACYT))