NCT02964767

Brief Summary

A cross sectional study would be done for prevalence of HIV-Tb. co infection among patients of HIV enrolled at ART centre, Khagaria, India, during June' 2015 to May' 2016. A comparative study of CD4 (cluster of differentiation 4) T cell count among HIV-Tb. co infected patient and HIV patients would be taken in account.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

October 4, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

November 5, 2016

Results QC Date

January 23, 2017

Last Update Submit

September 6, 2017

Conditions

Keywords

HIVHIV-Tb co infectionCD4 Cell

Outcome Measures

Primary Outcomes (1)

  • Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.

    % Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%

    12 months

Secondary Outcomes (1)

  • Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.

    12 months

Study Arms (2)

HIV mono infection

HIV Patients do not have active Mycobacterium Tuberculosis infection

HIV-Tb. co infection

Patients with HIV and MycobacteriumTuberculosis co infections

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV population

You may qualify if:

  • Patients of HIV+ enrolled ART centre

You may not qualify if:

  • Lost to follow up patients (LFU)
  • Patients died before the treatment started
  • Children below 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ART centre, Sadar Hospital

Khagaria, Bihar, 851204, India

Location

Related Publications (4)

  • Festenstein F, Grange JM. Tuberculosis and the acquired immune deficiency syndrome. J Appl Bacteriol. 1991 Jul;71(1):19-30. No abstract available.

    PMID: 1894579BACKGROUND
  • Getahun H, Gunneberg C, Granich R, Nunn P. HIV infection-associated tuberculosis: the epidemiology and the response. Clin Infect Dis. 2010 May 15;50 Suppl 3:S201-7. doi: 10.1086/651492.

    PMID: 20397949BACKGROUND
  • Global Tuberculosis Report 2016, World Health Organisation, Geneva.

    BACKGROUND
  • Perrin F, Breen R, Lipman M. : HIV and Tuberculosis co-infection. ABC of HIV and AIDS. Michael W, et al (ed): Wiley-Blackwell, BMJ Publishing Group Limited 6:42-47,2012

    BACKGROUND

Limitations and Caveats

this is a cross sectional study; findings are limited to the patients attending ART centre.

Results Point of Contact

Title
Dr. Ranjan K Singh
Organization
SinghRK

Study Officials

  • Ranjan K Singh, M.D.

    Physician cum nodal officer, ART centre, Khagaria, India.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nodal officer of ART centre, Sadar Hospital.

Study Record Dates

First Submitted

November 5, 2016

First Posted

November 16, 2016

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

October 4, 2017

Results First Posted

August 7, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

Available IPD Datasets

Epidemiological report Access
Clinical Study Report Access

Locations