Human Immunodeficiency VirusNCT06531772
Characteristics and Outcomes of TB and HIV Co-infections
An observational study of Human Immunodeficiency Virus and Mycobacterium Tuberculosis, run by Assiut University at 1 site in Egypt.
Trial summary
People Living with HIV (PLHIV) are prone to several opportunistic infections depending on the degree of immunosuppression as well as infections prevalent in their geographic area/country. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human Immunodeficiency Virus, Mycobacterium Tuberculosis
- What is being tested?
- Antitubercular Agents
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Mar 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients visiting Tuberculosis clinic - Assiut university hospitals for receiving antitubercular medicines will be divided into 2 groups either; A- Tuberculosis Cases, or B- Tuberculosis-HIV coinfection
Who may be able to join
- Laboratory diagnosis of TB-HIV co-infection
Who cannot join
- Patients refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Assiut University
Asyut, 711111
waleed MD Gamal Elddin Khaleel, Ass. Prof., +201006519722, waleed_gamal@aun.edu.eg
Manal MD Ahmed Mahmoud, Ass. Prof., 01009493236, manal_elkhawaga@yahoo.com
About this study
People Living with HIV (PLHIV) are prone to several opportunistic infections depending on the degree of immunosuppression as well as infections prevalent in their geographic area/country. These include a wide variety of mycobacterial diseases, fungal infections, bacterial pneumonias, pneumocystis jirovecii pneumonia, cryptococcal infections, toxoplasmosis etc.
Tuberculosis remains the most common opportunistic infection in the developing countries like South Africa and India.
Read more
HIV and tuberculosis (TB) are two of the most challenging infections faced by the humanity. HIV is the most important risk factor for progression of latent Mycobacterium tuberculosis (MTB) to active disease. The most common cause of death among PLHIV is tuberculosis. These two infections place immense burden on health care systems worldwide. During the last two decades, sustained research and public health initiatives on prevention and therapeutic advances have allayed morbidity and mortality due to HIV and TB to a large extent, however more needs to be done.
Globally, an estimated 10 million people fell ill with TB and an estimated 1.4 million people died of TB in 2018 (1.2 million among HIV negative and 251 000 among HIV positive people). There were around 37.9 million PLHIV worldwide in 2018.
In the pre-antiretroviral therapy (ART) era, nearly one-third of HIV/AIDS (acquired immune deficiency syndrome) related deaths were due to TB. Wider availability of ART has reduced the mortality of HIV-associated TB significantly, but it still remains high compared to HIV-uninfected individuals. The mortality risk with HIV TB coinfection accounts for approximately 25% of global HIV/AIDS deaths every year.
This study aims to investigate characteristics and outcomes of TB and HIV co-infections in Upper Egypt.
Read the detailed description
People Living with HIV (PLHIV) are prone to several opportunistic infections depending on the degree of immunosuppression as well as infections prevalent in their geographic area/country. These include a wide variety of mycobacterial diseases, fungal infections, bacterial pneumonias, pneumocystis jirovecii pneumonia, cryptococcal infections, toxoplasmosis etc.
Tuberculosis remains the most common opportunistic infection in the developing countries like South Africa and India.
HIV and tuberculosis (TB) are two of the most challenging infections faced by the humanity. HIV is the most important risk factor for progression of latent Mycobacterium tuberculosis (MTB) to active disease. The most common cause of death among PLHIV is tuberculosis. These two infections place immense burden on health care systems worldwide. During the last two decades, sustained research and public health initiatives on prevention and therapeutic advances have allayed morbidity and mortality due to HIV and TB to a large extent, however more needs to be done.
Globally, an estimated 10 million people fell ill with TB and an estimated 1.4 million people died of TB in 2018 (1.2 million among HIV negative and 251 000 among HIV positive people). There were around 37.9 million PLHIV worldwide in 2018.
In the pre-antiretroviral therapy (ART) era, nearly one-third of HIV/AIDS (acquired immune deficiency syndrome) related deaths were due to TB. Wider availability of ART has reduced the mortality of HIV-associated TB significantly, but it still remains high compared to HIV-uninfected individuals. The mortality risk with HIV TB coinfection accounts for approximately 25% of global HIV/AIDS deaths every year.
This study aims to investigate characteristics and outcomes of TB and HIV co-infections in Upper Egypt.
- Being tested
- Antitubercular Agents
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antitubercular AgentsDrug
Full regimen of antitubercular drugs for 6 month period or longer as justified by patient condition
| Study group | Role | What they receive |
|---|---|---|
| Tuberculosis without HIV | Not described Receives: Drug: Antitubercular Agents | |
| Tuberculosis with HIV Coinfection | Not described Receives: Drug: Antitubercular Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate for tuberculosis infection
complete cure from tuberculosis infection assessed by sputum conversion, general condition improvement and radiological improvement.
Measured: 6 months
Secondary outcomes (1)
pulmonary complications associated with tuberculosis in both groups
Superimposed pneumonia, opportunistic infection, pneumothorax, respiratory failure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed MD Gamal Elddin Khaleel, Ass. Prof., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531772
- Sponsor's protocol ID
- WG72024
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khadka P, Thapaliya J, Basnet RB, Ghimire GR, Amatya J, Rijal BP. Diagnosis of tuberculosis from smear-negative presumptive TB cases using Xpert MTB/Rif assay: a cross-sectional study from Nepal. BMC Infect Dis. 2019 Dec 30;19(1):1090. doi: 10.1186/s12879-019-4728-2.
PubMed 31888522Agarwal U, Kumar A, Behera D. Profile of HIV associated tuberculosis at a tertiary institute in setting of free anti-retroviral therapy. J Assoc Physicians India. 2009 Oct;57:685-90.
PubMed 20329424Yang Q, Han J, Shen J, Peng X, Zhou L, Yin X. Diagnosis and treatment of tuberculosis in adults with HIV. Medicine (Baltimore). 2022 Sep 2;101(35):e30405. doi: 10.1097/MD.0000000000030405.
PubMed 36107594
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of TB and HIV Co-infections
- ClinicalTrials.gov ID
- NCT06531772
- Acronym / sponsor ID
- WG72024
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 Aug 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.
People Living with HIV (PLHIV) are prone to several opportunistic infections depending on the degree of immunosuppression as well as infections prevalent in their geographic area/country. These include a wide variety of mycobacterial diseases, fungal infections, bacterial pneumonias, pneumocystis jirovecii pneumonia, cryptococcal infections, toxoplasmosis etc.
Tuberculosis remains the most common opportunistic infection in the developing countries like South Africa and India.
HIV and tuberculosis (TB) are two of the most challenging infections faced by the humanity. HIV is the most important risk factor for progression of latent Mycobacterium tuberculosis (MTB) to active disease. The most common cause of death among PLHIV is tuberculosis. These two infections place immense burden on health care systems worldwide. During the last two decades, sustained research and public health initiatives on prevention and therapeutic advances have allayed morbidity and mortality due to HIV and TB to a large extent, however more needs to be done.
Globally, an estimated 10 million people fell ill with TB and an estimated 1.4 million people died of TB in 2018 (1.2 million among HIV negative and 251 000 among HIV positive people). There were around 37.9 million PLHIV worldwide in 2018.
In the pre-antiretroviral therapy (ART) era, nearly one-third of HIV/AIDS (acquired immune deficiency syndrome) related deaths were due to TB. Wider availability of ART has reduced the mortality of HIV-associated TB significantly, but it still remains high compared to HIV-uninfected individuals. The mortality risk with HIV TB coinfection accounts for approximately 25% of global HIV/AIDS deaths every year.
This study aims to investigate characteristics and outcomes of TB and HIV co-infections in Upper Egypt.
Detailed description
People Living with HIV (PLHIV) are prone to several opportunistic infections depending on the degree of immunosuppression as well as infections prevalent in their geographic area/country. These include a wide variety of mycobacterial diseases, fungal infections, bacterial pneumonias, pneumocystis jirovecii pneumonia, cryptococcal infections, toxoplasmosis etc.
Tuberculosis remains the most common opportunistic infection in the developing countries like South Africa and India.
HIV and tuberculosis (TB) are two of the most challenging infections faced by the humanity. HIV is the most important risk factor for progression of latent Mycobacterium tuberculosis (MTB) to active disease. The most common cause of death among PLHIV is tuberculosis. These two infections place immense burden on health care systems worldwide. During the last two decades, sustained research and public health initiatives on prevention and therapeutic advances have allayed morbidity and mortality due to HIV and TB to a large extent, however more needs to be done.
Globally, an estimated 10 million people fell ill with TB and an estimated 1.4 million people died of TB in 2018 (1.2 million among HIV negative and 251 000 among HIV positive people). There were around 37.9 million PLHIV worldwide in 2018.
In the pre-antiretroviral therapy (ART) era, nearly one-third of HIV/AIDS (acquired immune deficiency syndrome) related deaths were due to TB. Wider availability of ART has reduced the mortality of HIV-associated TB significantly, but it still remains high compared to HIV-uninfected individuals. The mortality risk with HIV TB coinfection accounts for approximately 25% of global HIV/AIDS deaths every year.
This study aims to investigate characteristics and outcomes of TB and HIV co-infections in Upper Egypt.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuberculosis without HIV | – | Drug: Antitubercular Agents |
| Tuberculosis with HIV Coinfection | – | Drug: Antitubercular Agents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients visiting Tuberculosis clinic - Assiut university hospitals for receiving antitubercular medicines will be divided into 2 groups either; A- Tuberculosis Cases, or B- Tuberculosis-HIV coinfection
Key inclusion criteria (1 listed)
- Laboratory diagnosis of TB-HIV co-infection
Key exclusion criteria (1 listed)
- Patients refusing to participate in the study
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 |
|---|---|---|
| Antitubercular AgentsFull regimen of antitubercular drugs for 6 month period or longer as justified by patient condition | Drug | Tuberculosis with HIV Coinfection, Tuberculosis without HIV |
Primary outcome
Cure rate for tuberculosis infection
Time frame: 6 months
complete cure from tuberculosis infection assessed by sputum conversion, general condition improvement and radiological improvement.
1 secondary outcome
pulmonary complications associated with tuberculosis in both groups
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 31888522Khadka P, Thapaliya J, Basnet RB, Ghimire GR, Amatya J, Rijal BP. Diagnosis of tuberculosis from smear-negative presumptive TB cases using Xpert MTB/Rif assay: a cross-sectional study from Nepal. BMC Infect Dis. 2019 Dec 30;19(1):1090. doi: 10.1186/s12879-019-4728-2.
- Background: PubMed 20329424Agarwal U, Kumar A, Behera D. Profile of HIV associated tuberculosis at a tertiary institute in setting of free anti-retroviral therapy. J Assoc Physicians India. 2009 Oct;57:685-90.
- Background: PubMed 36107594Yang Q, Han J, Shen J, Peng X, Zhou L, Yin X. Diagnosis and treatment of tuberculosis in adults with HIV. Medicine (Baltimore). 2022 Sep 2;101(35):e30405. doi: 10.1097/MD.0000000000030405.
- Individual participant dataSharing planned: Undecided
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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.
Waleed MD Gamal Elddin Khaleel, Ass. Prof. principal investigator
Assiut University
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 Human Immunodeficiency Virus and Mycobacterium Tuberculosis, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed MD Gamal Elddin Khaleel, Ass. Prof. (+201006519722, waleed_gamal@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate for tuberculosis infection (time frame: 6 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 NCT06531772, which also lists 3 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 1 Aug 2024.