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

Secretariat of Health

Status and phase: Unknown; Phase 4

Conditions: Latent Tuberculosis Infection (LTI); Tuberculosis (TB); Human Immunodeficiency Virus (HIV)

Treatments: Drug: Isoniazid

Study type: Interventional

Funder types: Other

Identifiers

NCT01875952

Informed Consent:552 / 306

000000000014520 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

one arm

Other group

Description:

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

Treatment:

Drug: Isoniazid