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Human Immunodeficiency Virus (HIV)Phase 4HIV/TBNCT01875952

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

A Phase 4 study testing Isoniazid in people with Human Immunodeficiency Virus (HIV) and Tuberculosis (TB), run by Instituto Nacional de Salud Publica, Mexico at 2 sites in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Isoniazid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesMexico
Study dates
May 2010to Jun 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Allergy or intolerance to isoniazid
  • Peripheral neuropathy
  • Ingestion of drugs interacting with isoniazid

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

  • Instituto Nacional de Salud Publica

    México, Cuernavaca Morelos, 62100

  • Clínica Especializada CONDESA

    Mexico City, D.F, 06140

Other trials in Mexico

About this study

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

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

Read the 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).

Being tested
Isoniazid
Keywords
Latent tuberculosis infection, Human immunodeficiency virus (HIV), Treatment, Isoniazid
Medical subject headings
Acquired Immunodeficiency Syndrome, Tuberculosis, Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsoniazidDrug

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

Study groups in NCT01875952
Study groupRoleWhat they receive
one armOtherAll patients with response to positive purified protein derivative (PPD) test are treated
Receives: Drug: Isoniazid

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Before and after treatment intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2013 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2012
  4. Study completionJun 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01875952
Sponsor's protocol ID
Informed Consent:552 / 306
Other IDs
000000000014520
Acronym
HIV/TB
Status last verified
Jun 2013
First submitted
28 Mar 2012
Last updated
12 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Isoniazid in people with Human Immunodeficiency Virus (HIV) and Tuberculosis (TB), run by Instituto Nacional de Salud Publica, Mexico at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Production of interferon gamma, in response to treatment of latent infection (time frame: Before and after treatment intake). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01875952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.

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