Comprehensive Diagnosis and Treatment Strategy for Opportunistic Fungal Infections in AIDS Patients

Guangzhou Medical University

Status: Unknown

Conditions: Opportunistic Fungal Infections

Treatments: Other: examination methods

Study type: Observational

Funder types: Other

Identifiers

NCT05153005

202034167

Details and patient eligibility

About

Opportunistic fungal infection is the most common opportunistic infection in AIDS patients, with the high mortality and recurrence rate due to the lack of standardized comprehensive diagnosis and treatment strategy. This project aims to combine traditional detection and observation indicators with molecular biology, serology and mass spectrometry identification technology to develop early screening and diagnostic strategies for opportunistic fungal infections in AIDS patients, explore scientific evaluation methods for anti-fungal efficacy and formulate comprehensive strategies for reducing the mortality and recurrence rate.

Full description

The research involves AIDS patients complicated with talaromycosis, PCP and cryptococcosis in the study.

The main contents:

1. To explore early screening and diagnostic strategies. To advance the application of taloromyces marneffeispecific mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification In clinical practice.
2. To develop scientific evaluation strategy of anti-fungal treatment effect. On the basis of routine clinical, laboratory, imaging indexes and QFC, qPCR, dd-PCR and serological quantitative detection methods were combined to explore strategies for evaluating anti-fungal efficacy. 3 .To determine the termination timing of secondary prevention To explore the scientific timing to terminate secondary prevention after ART, Combing CD4 + T cell count with plasma HIV RNA, HIV DNA of peripheral blood mononuclear cells (PBMC), CD4 + / CD8+ ratio and chronic immune activation index

Enrollment: 600 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age (16-70 years), male and female;
2. HIV-1 infected;
3. hospitalized patients with the signs or symptoms inferred to infection;
4. Initial CD4 cell count less than 200 cells/ul; HIV-1 RNA viral load was unlimited;
5. State Informed Consent for Free Treatment has been signed;
6. Good compliance and signing Informed Consent

Exclusion criteria

1. have been treated regularly in other hospitals or have been clearly diagnosed before admission;
2. Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.);
3. Pregnancy during the study period;
4. Hospital stay less than 7 days.

Trial design

600 participants in 3 patient groups

Talaromycosis

Description:

Participants: AIDS patients complicated with Talaromycosis. Intervention(s): To use the specific antigen of taloromyces marneffei which is mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and qPCR, dd-PCR and mass spectrometry identification in the diagnosis and efficacy evaluation of AIDS patients complicated with Talaromycosis.

Treatment:

Other: examination methods

Pneumocystis pneumonia

Description:

Participants: AIDS patients complicated with Pneumocystis pneumonia Intervention(s)：To use (1,3)- β- D-glucan (G antigen) , qPCR, dd-PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies.

Treatment:

Other: examination methods

Cryptococcus

Description:

Participants: AIDS patients complicated with Cryptococcus Intervention(s)：To use (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen(CrAg) serological detection, qPCR, DD PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies of disease.

Treatment:

Other: examination methods