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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV mono infection | HIV Patients do not have active Mycobacterium Tuberculosis infection | ||
| HIV-Tb. co infection | Patients with HIV and MycobacteriumTuberculosis co infections |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases. | CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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HIV population
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| Name | Affiliation | Role |
|---|---|---|
| Ranjan K Singh, M.D. | Physician cum nodal officer, ART centre, Khagaria, India. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ART centre, Sadar Hospital | Khagaria | Bihar | 851204 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1894579 | Background | Festenstein F, Grange JM. Tuberculosis and the acquired immune deficiency syndrome. J Appl Bacteriol. 1991 Jul;71(1):19-30. No abstract available. | |
| 20397949 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Epidemiological report | View IPD |
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patients, who were Lost to Follow Up (LFU), were excluded from study.
Patients with HIV infection enrolled at ART centre, Khagaria, India, during June'2015 to May'2016 were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV, | HIV mono infected patients, |
| FG001 | HIV/Tb. | Patients with HIV/Tb. co infection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.HIV | patients with mono HIV infections |
| BG001 | 2.HIV/Tb. | Patients with HIV/Tb. co infections |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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% | Posted | Number | participants | 12 months |
|
|
12 months
other opportunistic infections
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV, | HIV patients | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| giddiness | Nervous system disorders | tablet default | Non-systematic Assessment | caused by ART drug Efavirenz. |
this is a cross sectional study; findings are limited to the patients attending ART centre.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ranjan K Singh | SinghRK | 91+9431263911 | dr_ranjankumarsingh@yahoo.com |
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| Background | 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 |
| Clinical Study Report | View IPD |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
|
| Secondary | Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases. | CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated. | Posted | Mean | Standard Deviation | cells/µL | 12 months |
|
|
|
|
| 171 |
| 0 |
| 171 |
| 6 |
| 171 |
| EG001 | HIV/Tb. co Infections | Patients with HIV-Tb. co infections | 0 | 48 | 0 | 48 | 2 | 48 |
|
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