HIV
Conditions
Keywords
HIV, HIV-Tb co infection, CD4 Cell
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.
Interventions
None listed
Sponsors
Singh, Ranjan Kumar, M.D.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center. | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases. | 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. |
Countries
India
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 1.HIV patients with mono HIV infections | 171 |
| 2.HIV/Tb. Patients with HIV/Tb. co infections | 48 |
| Total | 219 |
Baseline characteristics
| Characteristic | 1.HIV | 2.HIV/Tb. | Total |
|---|---|---|---|
| Age, Continuous | 33.26 years STANDARD_DEVIATION 12.77 | 34.97 years STANDARD_DEVIATION 11.21 | 33.63 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 80 Participants | 14 Participants | 94 Participants |
| Sex: Female, Male Male | 91 Participants | 34 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 171 | 0 / 48 |
| other Total, other adverse events | 6 / 171 | 2 / 48 |
| serious Total, serious adverse events | 0 / 171 | 0 / 48 |
Outcome results
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%
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevalence of HIV/Tb. co Infection | Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center. | 48 participants |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prevalence of HIV/Tb. co Infection | Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases. | 314.63 cells/µL | Standard Deviation 317.49 |
| 2.HIV/Tb. | Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases. | 254.29 cells/µL | Standard Deviation 218.19 |
p-value: <0.049t-test, 2 sided