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

• Conditions: Opportunistic Fungal Infections
• Interventions: Other: examination methods

• Registration Number: NCT05153005
• Lead Sponsor: Guangzhou 8th People's Hospital

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-11-15
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-10
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-13
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Talaromycosis	examination methods	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.
Pneumocystis pneumonia	examination methods	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.
Cryptococcus	examination methods	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.

Primary Outcome Measures

Name	Time	Method
The number of patients who achieved etiological diagnosis of opportunistic fungal infection	2 weeks	The probability of etiological diagnosis achieved by new diagnostic techniques after admission
Number of hospitalized patients who achieved clinical remission or cure	6 months	The improvement of treatment efficiency for treating with 3 main opportunistic fungal infections in AIDS patients when applying with new diagnostic techniques

Trial Locations

Locations (1)

Guangzhou Eighth People's Hospital, Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China