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

This study is ongoing, but not recruiting participants.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01875952
First received: March 28, 2012
Last updated: June 11, 2013
Last verified: June 2013

March 28, 2012
June 11, 2013
May 2010
June 2012   (final data collection date for primary outcome measure)
Production of interferon gamma, in response to treatment of latent infection [ Time Frame: Before and after treatment intake ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01875952 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL)
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

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).

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Human Immunodeficiency Virus (HIV)
  • Tuberculosis (TB)
  • Latent Tuberculosis Infection (LTI)
Drug: Isoniazid
Isoniazid, 10 mg/Kg/day, no more than 300 mg/day, for six months
Other Name: Isoniazid
one arm
All patients with response to positive purified protein derivative (PPD) test are treated
Intervention: Drug: Isoniazid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01875952
Informed Consent:552 / 306, 000000000014520
No
Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico
Instituto Nacional de Salud Publica, Mexico
  • Instituto Nacional de Enfermedades Respiratorias
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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)
Instituto Nacional de Salud Publica, Mexico
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP