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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01875952
Acronym
HIV/TB
Enrollment
100
Registered
2013-06-12
Start date
2010-05-31
Completion date
2013-06-30
Last updated
2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

DRUGIsoniazid

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

Sponsors

Instituto Nacional de Enfermedades Respiratorias
CollaboratorOTHER_GOV
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
CollaboratorOTHER
Instituto Nacional de Salud Publica, Mexico
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Production of interferon gamma, in response to treatment of latent infectionBefore and after treatment intake

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026