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NCT Number: NCT06531772

Characteristics and Outcomes of TB and HIV Co-infections

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Assiut University

Asyut, 711111, Egypt

Location status: Recruiting

Location contact

Amal MD Adel Rayan, Lecturer

PRINCIPAL_INVESTIGATOR

Haidi MD Karam-Allah Ramadan, Ass. Prof.

PRINCIPAL_INVESTIGATOR

Manal MD Ahmed Mahmoud, Ass. Prof.

CONTACT

[email protected]

01009493236

Manal MD Ahmed Mahmoud, Ass. Prof.

PRINCIPAL_INVESTIGATOR

waleed MD Gamal Elddin Khaleel, Ass. Prof.

CONTACT

[email protected]

+201006519722

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Laboratory diagnosis of TB-HIV co-infection

Exclusion criteria

  • Patients refusing to participate in the study

Treatment and study plan

Antitubercular Agents

Drug

Full regimen of antitubercular drugs for 6 month period or longer as justified by patient condition

Primary outcomes

  1. Cure rate for tuberculosis infection

    Time frame: 6 months

    complete cure from tuberculosis infection assessed by sputum conversion, general condition improvement and radiological improvement.

Secondary outcomes

  1. pulmonary complications associated with tuberculosis in both groups

    Time frame: 1 year

    Superimposed pneumonia, opportunistic infection, pneumothorax, respiratory failure

Study contacts

Contact information is provided by the study sponsor or research team.

Manal MD Ahmed Mahmoud, Ass. Prof.

CONTACT

[email protected]

+201009493236

Waleed MD Gamal Elddin Khaleel, Ass. Prof.

CONTACT

[email protected]

+201006519722

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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