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

Primary Purpose

Human Immunodeficiency Virus (HIV), Tuberculosis (TB), Latent Tuberculosis Infection (LTI)

Status

Unknown status

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Isoniazid

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) focused on measuring Latent tuberculosis infection, Human immunodeficiency virus (HIV), Treatment, Isoniazid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Instituto Nacional de Salud Publica
Clínica Especializada CONDESA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

one arm

Arm Description

All patients with response to positive purified protein derivative (PPD) test are treated

Outcomes

Primary Outcome Measures

Production of interferon gamma, in response to treatment of latent infection

Secondary Outcome Measures

Full Information

NCT ID

NCT01875952

First Posted

March 28, 2012

Last Updated

June 11, 2013

Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

Instituto Nacional de Enfermedades Respiratorias, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

1. Study Identification

Unique Protocol Identification Number

NCT01875952

Brief Title

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

Acronym

HIV/TB

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 Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

Instituto Nacional de Enfermedades Respiratorias, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee

5. 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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus (HIV), Tuberculosis (TB), Latent Tuberculosis Infection (LTI)

Keywords

Latent tuberculosis infection, Human immunodeficiency virus (HIV), Treatment, Isoniazid

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

one arm

Arm Type

Other

Arm Description

All patients with response to positive purified protein derivative (PPD) test are treated

Intervention Type

Drug

Intervention Name(s)

Isoniazid

Intervention Description

Isoniazid, 10 mg/Kg/day, no more than 300 mg/day, for six months

Primary Outcome Measure Information:

Title

Production of interferon gamma, in response to treatment of latent infection

Time Frame

Before and after treatment intake

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: