HIV InfectionNCT06671808
HIV and Multi-Drug Resistant Tuberculosis: a Study on Clinical Outcomes
An observational study of HIV Infection and MDR-TB, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
This study aims to investigate the relationship between HIV infection and multi-drug resistant tuberculosis (MDR-TB) among affected individuals in Zahedan, Iran. It will involve a detailed analysis of patient demographics, clinical characteristics, and treatment outcomes to enhance understanding of this co-infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, MDR-TB
- What is being tested?
- Examination of HIV Infection in Patients with Multi-Drug Resistant Tuberculosis (MDR-TB)
- How many people
- 222,128 participants
- Where
- 1 siteIran
- Study dates
- 15 May 2024to 3 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult individuals (aged 18 years and older) diagnosed with both HIV infection and multi-drug-resistant tuberculosis (MDR-TB). This meta-analysis synthesizes data from various studies conducted across multiple countries, including Brazil, the USA, Canada, India, Ethiopia, and several others. The population includes a diverse cohort of patients, reflecting various demographic characteristics such as age, sex, and geographical location. The studies included in this meta-analysis feature participants with confirmed diagnoses of HIV and MDR-TB, with a focus on understanding the co-infection dynamics, treatment outcomes, and associated health challenges. Data extraction from these studies provides insight into the prevalence and impact of MDR-TB among HIV-positive patients, highlighting the importance of tailored
Who may be able to join
- Adults (aged 18 years and older) diagnosed with both HIV and multi-drug-resistant tuberculosis (MDR-TB).
- Studies published in peer-reviewed journals.
- Studies that provide data on the co-occurrence of HIV and MDR-TB.
- Participants from diverse geographical regions to enhance generalizability.
- Studies with clear definitions of MDR-TB according to WHO guidelines.
Who cannot join
- Studies that focus solely on drug-susceptible tuberculosis without MDR-TB.
- Studies involving pediatric populations (under 18 years of age).
- Non-original research such as reviews, editorials, and commentaries.
- Studies lacking sufficient data on the co-occurrence of HIV and MDR-TB.
- Studies that do not adhere to ethical guidelines for human subjects or lack appropriate ethical approvals.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Zahedan University of Medical Sciences
Zahedan, Sistan and Baluchestan, 98167-43463
About this study
Official title: HIV Infection Accompanied by Multi-Drug Resistant Tuberculosis: a Decadal Systematic Review and Meta-Analysis
This study aims to investigate the relationship between HIV infection and multi-drug resistant tuberculosis (MDR-TB) among affected individuals in Zahedan, Iran. It will involve a detailed analysis of patient demographics, clinical characteristics, and treatment outcomes to enhance understanding of this co-infection. The findings may inform better treatment strategies and healthcare policies for managing these diseases in similar populations.
- Conditions
- HIV Infection, MDR-TB
- Being tested
- Examination of HIV Infection in Patients with Multi-Drug Resistant Tuberculosis (MDR-TB)
- Medical subject headings
- HIV Infections, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of HIV Infection in Patients with Multi-Drug Resistant Tuberculosis (MDR-TB)Other
This meta-analysis examines the impact of HIV infection on the prevalence and outcomes of multi-drug resistant tuberculosis (MDR-TB) among affected populations. The analysis synthesizes data from multiple studies conducted across various countries, focusing on the correlation between HIV co-infection and MDR-TB rates, treatment outcomes, and demographic factors. The findings aim to enhance understanding of the complex interactions between HIV and MDR-TB, ultimately informing clinical practices and public health strategies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Multi-Drug Resistant Tuberculosis (MDR-TB) in HIV-Positive Patients
This study aims to determine the prevalence of multi-drug resistant tuberculosis (MDR-TB) among patients co-infected with HIV. Data will be collected from various studies included in the meta-analysis, focusing on the incidence rates of MDR-TB in this population. The analysis will provide insights into the challenges faced in treating HIV-positive individuals with MDR-TB and highlight the need for targeted interventions.
Measured: Data collected over the course of the studies from 2006 to 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start15 May 2024
- Primary completion22 Aug 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Retrospective
- Enrolment
- 222,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Kouhpayeh, Zahedan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671808
- Sponsor's protocol ID
- HIVTB2024
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Infection Accompanied by Multi-Drug Resistant Tuberculosis: a Decadal Systematic Review and Meta-Analysis
- ClinicalTrials.gov ID
- NCT06671808
- Acronym / sponsor ID
- HIVTB2024
- Conditions
- HIV Infection, MDR-TB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222,128 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the relationship between HIV infection and multi-drug resistant tuberculosis (MDR-TB) among affected individuals in Zahedan, Iran. It will involve a detailed analysis of patient demographics, clinical characteristics, and treatment outcomes to enhance understanding of this co-infection. The findings may inform better treatment strategies and healthcare policies for managing these diseases in similar populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult individuals (aged 18 years and older) diagnosed with both HIV infection and multi-drug-resistant tuberculosis (MDR-TB). This meta-analysis synthesizes data from various studies conducted across multiple countries, including Brazil, the USA, Canada, India, Ethiopia, and several others. The population includes a diverse cohort of patients, reflecting various demographic characteristics such as age, sex, and geographical location. The studies included in this meta-analysis feature participants with confirmed diagnoses of HIV and MDR-TB, with a focus on understanding the co-infection dynamics, treatment outcomes, and associated health challenges. Data extraction from these studies provides insight into the prevalence and impact of MDR-TB among HIV-positive patients, highlighting the importance of tailored
Key inclusion criteria (5 listed)
- Adults (aged 18 years and older) diagnosed with both HIV and multi-drug-resistant tuberculosis (MDR-TB).
- Studies published in peer-reviewed journals.
- Studies that provide data on the co-occurrence of HIV and MDR-TB.
- Participants from diverse geographical regions to enhance generalizability.
- Studies with clear definitions of MDR-TB according to WHO guidelines.
Key exclusion criteria (5 listed)
- Studies that focus solely on drug-susceptible tuberculosis without MDR-TB.
- Studies involving pediatric populations (under 18 years of age).
- Non-original research such as reviews, editorials, and commentaries.
- Studies lacking sufficient data on the co-occurrence of HIV and MDR-TB.
- Studies that do not adhere to ethical guidelines for human subjects or lack appropriate ethical approvals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination of HIV Infection in Patients with Multi-Drug Resistant Tuberculosis (MDR-TB)This meta-analysis examines the impact of HIV infection on the prevalence and outcomes of multi-drug resistant tuberculosis (MDR-TB) among affected populations. The analysis synthesizes data from multiple studies conducted across various countries, focusing on the correlation between HIV co-infection and MDR-TB rates, treatment outcomes, and demographic factors. The findings aim to enhance understanding of the complex interactions between HIV and MDR-TB, ultimately informing clinical practices and public health strategies. | Other | – |
Primary outcome
Prevalence of Multi-Drug Resistant Tuberculosis (MDR-TB) in HIV-Positive Patients
Time frame: Data collected over the course of the studies from 2006 to 2018.
This study aims to determine the prevalence of multi-drug resistant tuberculosis (MDR-TB) among patients co-infected with HIV. Data will be collected from various studies included in the meta-analysis, focusing on the incidence rates of MDR-TB in this population. The analysis will provide insights into the challenges faced in treating HIV-positive individuals with MDR-TB and highlight the need for targeted interventions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infection and MDR-TB, run by Zahedan University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 5 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 Nov 2024. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Multi-Drug Resistant Tuberculosis (MDR-TB) in HIV-Positive Patients (time frame: Data collected over the course of the studies from 2006 to 2018.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024.