Characteristics and Outcomes of TB and HIV Co-infections

NCT ID: NCT06531772

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-03-01

Brief Summary

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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

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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.

Conditions

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Human Immunodeficiency Virus Mycobacterium Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Tuberculosis without HIV

Antitubercular Agents

Intervention Type DRUG

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

Tuberculosis with HIV Coinfection

Antitubercular Agents

Intervention Type DRUG

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

Interventions

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Antitubercular Agents

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Laboratory diagnosis of TB-HIV co-infection

Exclusion Criteria

* Patients refusing to participate in the study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Waleed Gamal Elddin Khaleel

Assistant Professor of Chest Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed MD Gamal Elddin Khaleel, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Faculty of Medicine, Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Waleed MD Gamal Elddin Khaleel, Ass. Prof.

Role: CONTACT

+201006519722

Manal MD Ahmed Mahmoud, Ass. Prof.

Role: CONTACT

+201009493236

Facility Contacts

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waleed MD Gamal Elddin Khaleel, Ass. Prof.

Role: primary

+201006519722

Manal MD Ahmed Mahmoud, Ass. Prof.

Role: backup

01009493236

References

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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.

Reference Type BACKGROUND
PMID: 31888522 (View on PubMed)

Agarwal 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.

Reference Type BACKGROUND
PMID: 20329424 (View on PubMed)

Yang 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.

Reference Type BACKGROUND
PMID: 36107594 (View on PubMed)

Other Identifiers

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WG72024

Identifier Type: -

Identifier Source: org_study_id

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