NCT00692809

Brief Summary

HIV induced altered representation and function of regulatory T cell subsets (NKT and Treg cells) impair the protective T cell response against M.tuberculosis and disrupts LTBI, thus facilitates faster progression and development of severe forms of clinical TB in HIV-TB co-infection.

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
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 15, 2009

Status Verified

June 1, 2008

Enrollment Period

1.7 years

First QC Date

June 5, 2008

Last Update Submit

September 14, 2009

Conditions

Latent Tuberculosis InfectionHIV InfectionsTuberculosis

Keywords

Latent tuberculosis infectionHuman immunodeficiency virusTuberculosisNatural Killer T CellsInvariant Natural Killer T CellsRegulatory T cellsInterferon-gamma

Outcome Measures

Primary Outcomes (1)

  • Precise component(s) of T cell response against M.tuberculosis compromised by HIV infection which leads to the development of severe forms of clinical tuberculosis.

    5 months

Secondary Outcomes (1)

  • Elucidation of critical events of the cellular and molecular interactions that would be useful for developing newer therapeutic strategies and vaccination.

    5 months

Study Arms (4)

1

HIV+ve+LTBI (n=100)

2

HIV+ve+clinical TB (n=50)

3

HIV-ve+clinical TB (n=15)

4

Normal control (n=15)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV+ve+LTBI HIV+ve+clinical TB HIV-ve+clinical TB Normal control

You may qualify if:

  • HIV infected +LTBI group:
  • Patient of either sex between 18-65 years of age
  • All the patients should be HIV ELISA test positive irrespective of CD4 count and presence of other opportunistic infections Antiretroviral drug naive HIV patients
  • No past history of TB
  • Patients should be either tuberculin test positive (\> 5mm) or interferon gamma release assay positive
  • Written informed consent to participate in the study given by participants or legal guardian
  • Patients able to comply with instructions and come back for a regular follow up
  • HIV infected + Clinical TB group:
  • Patient of either sex between 18-65 years of age
  • All the patients should be HIV ELISA test positive irrespective of CD4 count and presence of other opportunistic infections
  • In PTB group, patient should be two sputum smear positive out of three consecutive samples
  • In EPTB group, diagnosis of TB will be:
  • Definitive -Culture confirmed
  • Probable -Histopathological or radiological -Clinical features and response to anti TB treatment (ATT)
  • Possible TB -Clinical feature and response to anti TB treatment (ATT)
  • +23 more criteria

You may not qualify if:

  • HIV infected +LTBI group:
  • Pregnant and lactating females
  • Patients who are getting steroid therapy
  • Transplant patients, diabetes mellitus or malignancy, chronic renal failure or liver diseases
  • Currently receiving cytotoxic therapy, or have received it within the last 3 months
  • Terminally ill as per treating clinician's judgment
  • Patient from outside Delhi and migrants
  • HIV infected + Clinical TB group:
  • Category II and multidrug-resistant pulmonary tuberculosis
  • Pregnant and lactating females
  • Patients who are getting steroid therapy
  • Transplant patients, diabetes mellitus or malignancy, chronic renal failure or liver diseases
  • Currently receiving cytotoxic therapy, or have received it within the last 3 months
  • Terminally ill patient as per treating clinician's judgment
  • Patients from outside Delhi and migrants
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110608, India

RECRUITING

MeSH Terms

Conditions

Latent TuberculosisHIV InfectionsTuberculosisAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Surendra K Sharma, M.D., Ph.D

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Surendra K Sharma, M.D., Ph.D

CONTACT

26594415surensk@gmail.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 6, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 15, 2009

Record last verified: 2008-06

Locations

IN(1)