HIVNCT02964767
HIV-Tb Confections Among HIV Patients
An observational study of HIV, run by Singh, Ranjan Kumar, M.D. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- HIV
- How many people
- 219 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2015to Nov 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV population
Who may be able to join
- Patients of HIV+ enrolled ART centre
Who cannot join
- Lost to follow up patients (LFU)
- Patients died before the treatment started
- Children below 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of HIV-Tb co Infections Among HIV Patients and Their CD4+ T Cell Status-A Single Centre Study in India
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.
Read the 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.
- Conditions
- HIV
- Keywords
- HIV, HIV-Tb co infection, CD4 Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV mono infection | HIV Patients do not have active Mycobacterium Tuberculosis infection | |
| HIV-Tb. co infection | Patients with HIV and MycobacteriumTuberculosis co infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singh, Ranjan Kumar, M.D.
- Responsible party
- Principal investigator, Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.
- Investigators
- Ranjan K Singh, M.D., Principal investigator, Physician cum nodal officer, ART centre, Khagaria, India.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964767
- Sponsor's protocol ID
- SinghRK
- Status last verified
- Sep 2017
- First submitted
- 5 Nov 2016
- Last updated
- 4 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Festenstein F, Grange JM. Tuberculosis and the acquired immune deficiency syndrome. J Appl Bacteriol. 1991 Jul;71(1):19-30. No abstract available.
PubMed 1894579Getahun 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.
PubMed 20397949Global 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HIV-Tb co Infections Among HIV Patients and Their CD4+ T Cell Status-A Single Centre Study in India
- ClinicalTrials.gov ID
- NCT02964767
- Acronym / sponsor ID
- SinghRK
- Conditions
- HIV
- Keywords
- HIV, HIV-Tb co infection, CD4 Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Singh, Ranjan Kumar, M.D.
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV mono infection | – | –HIV Patients do not have active Mycobacterium Tuberculosis infection |
| HIV-Tb. co infection | – | –Patients with HIV and MycobacteriumTuberculosis co infections |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV population
Key inclusion criteria (1 listed)
- Patients of HIV+ enrolled ART centre
Key exclusion criteria (3 listed)
- Lost to follow up patients (LFU)
- Patients died before the treatment started
- Children below 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
1 secondary outcome
Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1894579Festenstein F, Grange JM. Tuberculosis and the acquired immune deficiency syndrome. J Appl Bacteriol. 1991 Jul;71(1):19-30. No abstract available.
- Background: PubMed 20397949Getahun 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.
- BackgroundGlobal Tuberculosis Report 2016, World Health Organisation, Geneva.
- BackgroundPerrin 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
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjan K Singh, M.D. principal investigator
Physician cum nodal officer, ART centre, Khagaria, India.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Singh, Ranjan Kumar, M.D. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02964767, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.