This trial is active, not recruiting.

Conditions human immunodeficiency virus (hiv), tuberculosis (tb), latent tuberculosis infection (lti)
Treatment isoniazid
Phase phase 4
Sponsor Instituto Nacional de Salud Publica, Mexico
Collaborator Instituto Nacional de Enfermedades Respiratorias
Start date May 2010
End date June 2012
Trial size 100 participants
Trial identifier NCT01875952, 000000000014520, Informed Consent:552 / 306


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
All patients with response to positive purified protein derivative (PPD) test are treated
isoniazid Isoniazid
Isoniazid, 10 mg/Kg/day, no more than 300 mg/day, for six months

Primary Outcomes

Production of interferon gamma, in response to treatment of latent infection
time frame: Before and after treatment intake

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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
Principal investigator José Sifuentes, Doctor
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Instituto Nacional de Salud Publica, Mexico.