NCT01875952

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2010

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

2.1 years

First QC Date

March 28, 2012

Last Update Submit

June 11, 2013

Conditions

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

Keywords

Latent tuberculosis infectionHuman immunodeficiency virus (HIV)TreatmentIsoniazid

Outcome Measures

Primary Outcomes (1)

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

    Before and after treatment intake

Study Arms (1)

one arm

OTHER

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

Drug: Isoniazid

Interventions

IsoniazidDRUG

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

one arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Nacional de Salud Publica

México, Cuernavaca Morelos, 62100, Mexico

Location

Clínica Especializada CONDESA

Mexico City, D.F, 06140, Mexico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeTuberculosisLatent Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesLatent Infection

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

  • Maria de Lourdes García-García, Post doctor

    Instituto Nacional de Salud Publica (INSP)

    STUDY DIRECTOR

  • Jose Luis Valdespino-Gómez, MD

    Laboratorios Nacionales de Biológicos y Reactrivos (BIRMEX)

    PRINCIPAL INVESTIGATOR

  • Martha Torres Rojas, Post Doctor

    National Institute of Respiratory Diseases (INER)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Center of Research in Infectious Diseases

Study Record Dates

First Submitted

March 28, 2012

First Posted

June 12, 2013

Study Start

May 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

ME(2)