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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05153005
Enrollment
600
Registered
2021-12-10
Start date
2021-04-01
Completion date
2023-12-31
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opportunistic Fungal Infections

Keywords

Talaromycosis, Pneumocystis pneumonia, Cryptococcus Infection

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

Interventions

OTHERexamination methods

Some advanced methods: mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification, QFC.

Sponsors

Guangzhou 8th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The number of patients who achieved etiological diagnosis of opportunistic fungal infection2 weeksThe probability of etiological diagnosis achieved by new diagnostic techniques after admission
Number of hospitalized patients who achieved clinical remission or cure6 monthsThe improvement of treatment efficiency for treating with 3 main opportunistic fungal infections in AIDS patients when applying with new diagnostic techniques

Countries

China

Contacts

Primary ContactLinghua Li, PhD
llheliza@126.com02083710825
Backup ContactPengle Guo, Master
lelegpl@qq.com02083710825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026