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

• Sponsor: Instituto Nacional de Salud Publica, Mexico (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01875952
• Collaborator: Instituto Nacional de Enfermedades Respiratorias (Other), Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
• Enrollment: 100
• Locations: 2
• Arm: 1
• Duration (Months): 37
• Patients Per Site: 50
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus (HIV); Tuberculosis (TB); Latent Tuberculosis Infection (LTI)	Drug: Isoniazid	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• 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
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Production of interferon gamma, in response to treatment of latent infection [Before and after treatment intake]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Salud Publica	Mexico	Cuernavaca Morelos	Mexico	62100
2	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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
• Other Study ID Numbers: Informed Consent:552 / 306; 000000000014520
• First Posted: Jun 12, 2013
• Last Update Posted: Jun 12, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Ma. de Lourdes Garcia Garcia, Director of the Center of Research in Infectious Diseases, Instituto Nacional de Salud Publica, Mexico: Latent tuberculosis infection; Human immunodeficiency virus (HIV); Treatment; Isoniazid
• Additional relevant MeSH terms: Infections; Communicable Diseases; Tuberculosis; Acquired Immunodeficiency Syndrome; HIV Infections; Latent Tuberculosis; Coinfection; Immunologic Deficiency Syndromes; Isoniazid

Study Results

No Results Posted as of Jun 12, 2013