AIDS
Conditions
Interventions
2:lenalidomide
1:PD-1 monoclonal antibody
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Cohort 1: immunomodulatory therapy was performed in patients with AIDS complicated with Cryptococcus meningitis (1) inpatients aged 18 to 65 years old; (2) HIV infection was confirmed by primary screening test and WB diagnosis test. Virus load detection is less than the minimum detection value; (3) patients with Cryptococcus meningitis were diagnosed as Cryptococcus meningitis: Cryptococcus in cerebrospinal fluid (cerebrospinal fluid) was positive or cultured in cerebrospinal fluid (cerebrospinal fluid), Cryptococcus vulgaris was found on smear, cerebrospinal fluid (cerebrospinal fluid) changes and MR showed intracranial lesions; (4) patients with AIDS complicated with tumor can no longer carry out routine surgical treatment or conventional chemotherapy can not alleviate the tumor; (5) voluntarily sign the informed consent form of the patient and ensure regular follow-up, specimen collection and related adverse reactions, and use contraceptives from 4 weeks before the beginning of the study to 4 weeks after the end of the study. Cohort 2: the effect of PD-1 monoclonal antibody on latent AIDS infection in patients with AIDS complicated with tumor. The main results were as follows: (1) inpatients aged 18 to 65 years old; (2) confirmed HIV infection by primary screening test and WB diagnostic test; (3) patients with diagnosed tumor were treated with PD-1 monoclonal antibody and willing to use it; (4) voluntarily signed the informed consent form of the patient, and could ensure regular follow-up, specimen collection and related adverse reactions.
Exclusion criteria
Exclusion criteria: Cohort 1: immunomodulatory therapy for patients with AIDS complicated with Cryptococcus meningitis (1) pregnancy, lactating women, or planned pregnancy during the observation period; (2) patients with poor compliance; (3) immunosuppressive agents or other immunomodulator or cytotoxicity drugs were treated within 6 months before screening; (4) patients with serious basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other taboo treatments; (5) unwilling to sign informed consent form of patients; (6) patients with basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other taboos in treatment. Cohort 2: the effect of PD-1 monoclonal antibody on latent AIDS infection in patients with AIDS complicated with tumor (1) treatment of patients with poor compliance; (2) immunosuppressive agents or other immunomodulators or cytotoxicity drugs were treated within 6 months before screening; (3) patients with serious basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other taboo treatments; (4) unwilling to sign informed consent form of patients; (5) patients with basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other treatment taboos.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV DNA;HIV RNA; | — |
Countries
China
Contacts
Public ContactBiao Zhu
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed