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HIV-Tb Confections Among HIV Patients

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ClinicalTrials.gov Identifier: NCT02964767
Recruitment Status : Completed
First Posted : November 16, 2016
Results First Posted : August 7, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.

Tracking Information
First Submitted Date November 5, 2016
First Posted Date November 16, 2016
Results First Submitted Date January 23, 2017
Results First Posted Date August 7, 2017
Last Update Posted Date October 4, 2017
Study Start Date June 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2017)
Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center. [ Time Frame: 12 months ]
% 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%
Original Primary Outcome Measures
 (submitted: November 15, 2016)
Prevalence of HIV-Tb. co infection among HIV patients enrolled at ART centre. [ Time Frame: 12 months ]
Prevalence of HIV-Tb. co infection=no. of HIV-Tb. patients/no. of HIV patients ×100.
Change History Complete list of historical versions of study NCT02964767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 2, 2017)
Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases. [ Time Frame: 12 months ]
CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.
Original Secondary Outcome Measures
 (submitted: November 15, 2016)
Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases. [ Time Frame: 12 months ]
Comparison of CD4 count would be done by chi square test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HIV-Tb Confections Among HIV Patients
Official Title Prevalence of HIV-Tb co Infections Among HIV Patients and Their CD4+ T Cell Status-A Single Centre Study in India
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.
Detailed Description

Introduction

HIV infection increases the susceptibility of Mycobacterium Tuberculosis (M.Tb.) infection, and hastens its progression due to changes in immune status of the patients. In fact, tuberculosis is now the most common opportunistic infection in patients, who die from AIDS. Immune response in tuberculosis and other infections induces cytokines that enhance replication of HIV, and derives the patient to full blown AIDS. the prevalence of HIV/Tb co-infections have been reported to 0.4% to 20.1% from different regions of northern part of india. India is one of the six countries, those are accounted for 60 percent new cases of tuberculosis, and the BRICS countries collectively account for approximately 50 perce

nt cases of worldwide tuberculosis. The prevalence of multidrug resistant tuberculosis(MDR-TB.) is two-threefold higher in HIV co-infected patients; as HIV infected people rapidly acquire the active disease including resistant strain of M. Tb. and rapidly transmit the disease among population including PLHIV, who in turn, manifest the active drug resistant tuberculosis.

Methods

  • This is cohort study among patients of HIV, attending ART (Antiretroviral therapy) center khagaria, Bihar, India during June' 2015 to May' 2016.
  • Patients enrolled at the centre were subjected to screening for Mycobacterium tuberculosis infection by doing ESR, mantoux test, chest x-ray, sputum examination for acid fast bacillus (AFB) and nucleic acid amplification test.
  • HIV/Tb co infected patients were given cotrimoxazole.
  • Patients' data-for example, age, sex, co infection with tuberculosis would be recorded.
  • Sputum positivity, radiological features, and extra pulmonary manifestations would be recorded and statistical analysis would be done
  • Statistical analysis, such as, mean, standard deviation(SD), student T test, p-values would be done. P-value significance would be measured at p < .05.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HIV population
Condition HIV
Intervention Not Provided
Study Groups/Cohorts
  • HIV mono infection
    HIV Patients do not have active Mycobacterium Tuberculosis infection
  • HIV-Tb. co infection
    Patients with HIV and MycobacteriumTuberculosis co infections
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 15, 2016)
219
Original Actual Enrollment Same as current
Actual Study Completion Date November 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients of HIV+ enrolled ART centre

Exclusion Criteria:

  • Lost to follow up patients (LFU)
  • Patients died before the treatment started
  • Children below 5 years
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT02964767
Other Study ID Numbers SinghRK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.
Study Sponsor Singh, Ranjan Kumar, M.D.
Collaborators Not Provided
Investigators
Principal Investigator: Ranjan K Singh, M.D. Physician cum nodal officer, ART centre, Khagaria, India.
PRS Account Singh, Ranjan Kumar, M.D.
Verification Date September 2017