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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.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV
Enrollment 219
Recruitment Details Patients with HIV infection enrolled at ART centre, Khagaria, India, during June'2015 to May'2016 were recruited.
Pre-assignment Details patients, who were Lost to Follow Up (LFU), were excluded from study.
Arm/Group Title HIV, HIV/Tb.
Hide Arm/Group Description HIV mono infected patients, Patients with HIV/Tb. co infection
Period Title: Overall Study
Started 171 48
Completed 171 48
Not Completed 0 0
Arm/Group Title 1.HIV 2.HIV/Tb. Total
Hide Arm/Group Description patients with mono HIV infections Patients with HIV/Tb. co infections Total of all reporting groups
Overall Number of Baseline Participants 171 48 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants 48 participants 219 participants
33.26  (12.77) 34.97  (11.21) 33.63  (11.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 48 participants 219 participants
Female 80 14 94
Male 91 34 125
1.Primary Outcome
Title Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.
Hide Description % 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%
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prevalence of HIV/Tb. co Infection
Hide Arm/Group Description:
Percentage of Tb. co infections among HIV patients enrolled at ART center.
Overall Number of Participants Analyzed 219
Measure Type: Number
Unit of Measure: participants
48
2.Secondary Outcome
Title Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.
Hide Description CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1.HIV 2.HIV/Tb.
Hide Arm/Group Description:
HIV patients only
Patients with HIV/Tb. co infections
Overall Number of Participants Analyzed 171 48
Mean (Standard Deviation)
Unit of Measure: cells/µL
314.63  (317.49) 254.29  (218.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1.HIV, 2.HIV/Tb.
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.049
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description other opportunistic infections
 
Arm/Group Title HIV, HIV/Tb. co Infections
Hide Arm/Group Description HIV patients Patients with HIV-Tb. co infections
All-Cause Mortality
HIV, HIV/Tb. co Infections
Affected / at Risk (%) Affected / at Risk (%)
Total   00/171 (0.00%)      00/48 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
HIV, HIV/Tb. co Infections
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/171 (0.00%)      0/48 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
HIV, HIV/Tb. co Infections
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/171 (3.51%)      2/48 (4.17%)    
Nervous system disorders     
giddiness * 1 [1]  6/171 (3.51%)  8 2/48 (4.17%)  6
1
Term from vocabulary, tablet default
*
Indicates events were collected by non-systematic assessment
[1]
caused by ART drug Efavirenz.
this is a cross sectional study; findings are limited to the patients attending ART centre.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ranjan K Singh
Organization: SinghRK
Phone: 91+9431263911
Publications:
Global Tuberculosis Report 2016, World Health Organisation, Geneva.
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
Responsible Party: Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.
ClinicalTrials.gov Identifier: NCT02964767     History of Changes
Other Study ID Numbers: SinghRK
First Submitted: November 5, 2016
First Posted: November 16, 2016
Results First Submitted: January 23, 2017
Results First Posted: August 7, 2017
Last Update Posted: October 4, 2017