Trial record 2 of 22 for:    " March 14, 2012":" April 13, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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
Other Name: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 28, 2012
Last Updated: June 11, 2013
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

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

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

ClinicalTrials.gov processed this record on August 20, 2014