We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
March 28, 2012
June 12, 2013
June 12, 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 ]
Same as current
No Changes Posted
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
Intervention Model: Single Group Assignment
Masking: None (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
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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01875952
Informed Consent:552 / 306
000000000014520 ( Other Identifier: National Council for Science and Technology (CONACYT) )
No
Not Provided
Not Provided
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