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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01875952
First Posted: June 12, 2013
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico
  Purpose
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

Condition Intervention Phase
Human Immunodeficiency Virus (HIV) Tuberculosis (TB) Latent Tuberculosis Infection (LTI) Drug: Isoniazid Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • Production of interferon gamma, in response to treatment of latent infection [ Time Frame: Before and after treatment intake ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875952


Locations
Mexico
Instituto Nacional de Salud Publica
Mexico, Cuernavaca Morelos, Mexico, 62100
Clínica Especializada CONDESA
Mexico City, D.F, Mexico, 06140
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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 Publica (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)
  More Information

Responsible Party: Ma. de Lourdes Garcia Garcia, Director of the Center of Research in Infectious Diseases, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT01875952     History of Changes
Other Study ID Numbers: Informed Consent:552 / 306
000000000014520 ( Other Identifier: National Council for Science and Technology (CONACYT) )
First Submitted: March 28, 2012
First Posted: June 12, 2013
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico:
Latent tuberculosis infection
Human immunodeficiency virus (HIV)
Treatment
Isoniazid

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Communicable Diseases
Immunologic Deficiency Syndromes
Tuberculosis
Latent Tuberculosis
Coinfection
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Parasitic Diseases
Isoniazid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents


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