Characteristics and Outcomes of TB and HIV Co-infections

NCT06531772 | Recruiting

• 1 other identifier: WG72024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Human Immunodeficiency Virus; Mycobacterium Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Cure rate for tuberculosis infection

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

  6 months

Secondary Outcomes (1)

• pulmonary complications associated with tuberculosis in both groups

  1 year

Study Arms (2)

Tuberculosis without HIV

Drug: Antitubercular Agents

Tuberculosis with HIV Coinfection

Drug: Antitubercular Agents

Interventions

Antitubercular Agents DRUG

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

Tuberculosis with HIV Coinfection; Tuberculosis without HIV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Laboratory diagnosis of TB-HIV co-infection

You may not qualify if:

• Patients refusing to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, 711111, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 31888522 BACKGROUND

• 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.

  PMID: 20329424 BACKGROUND

• 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.

  PMID: 36107594 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Antitubercular Agents

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Waleed MD Gamal Elddin Khaleel, Ass. Prof.

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed MD Gamal Elddin Khaleel, Ass. Prof.

CONTACT

+201006519722; waleed_gamal@aun.edu.eg

Manal MD Ahmed Mahmoud, Ass. Prof.

CONTACT

+201009493236; manal_elkhawaga@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Chest Diseases

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: September 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

EG (1)