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A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections

A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021195
Enrollment
Unknown
Registered
2019-02-01
Start date
2019-02-11
Completion date
Unknown
Last updated
2019-02-04

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

Conditions

AIDS opportunistic infections and refractory AIDS

Interventions

Task 1, Control group:No intervention is taken.
Task 1, Intervention group 1:Induction therapy: fluconazole 800mg/d, PO, for 2 weeks
consolidation therapy: fluconazole 400mg/d, PO, for 8 weeks
maintenance therapy: fluconazole 200mg/day, PO, for 1 year.
Task 1, Intervention group 2:Fluconazole 400mg / day, PO, for 1 year.
Task 2, Control group:When the initial intracranial pressure=250mmH2O, according to the patients' will, lumbar puncture and removing CSF should be done by regular.
Task 2, Therapeutic lumbar puncture group:When the initial intracranial pressure is = 250 mmH2O, lumbar puncture was given daily to reduce intracranial pressure. The intracranial pressure was measure
Task 2, Drainage group:When the initial intracranial pressure is =250mmH2O, the drainage is given, and the cerebrospinal fluid is continuously drained by the improved drainage device to maintain the d
when the intracranial pressure is <200mmH2O for 2 days or more, Stop drainage.
Task 3, Control group:Amphotericin B deoxycholate combined with flucytosine. Details: amphotericin B deoxycholate 0.5 - 0.7mg / kg, once a day, intravenous drip
flucytosine, daily 100mg / kg, divided into 4 times, PO. Lumbar puncture, biochemical examination of cerebrospinal fluid, cerebrospinal fluid ink staining and fungal culture were p
Task 3, Intervention group 1:Voriconazole combined with flucytosine. Details: Voriconazole was given orally at the induction dose of 400 mg on the first day, once every 12 hours, 200 mg on the second
Task 3, Intervention group 2:Amphotericin B deoxycholate combined with fluconazole. Details: Amphotericin B deoxycholate 0.5-0.7 mg/kg, once a day, intravenous dri

Sponsors

Chongqing Public health medical center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Impact of cryptococcal antigen screening and antifungal interventions on incidence of cryptococcal meningitis in HIV-infected patients: a multicenter prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcus antigenemia was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 2. Management strategies of high intracranial pressures in HIV-infected patients with cryptococcal meningitis: a multicenter prospective cohort study (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcal meningitis was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment; (6) Any lumbar puncture showed that the cerebral pressure= 250 mmH2O. 3. Efficiency and safety of antifungal regimens in HIV-infected patients with cryptococcal meningitis: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcal meningitis was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 4. Timing of antiretroviral therapy for HIV-infected patients with cryptococcal meningitis: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Cryptococcal meningitis was clinically diagnosed; (4) Have not received any antiretroviral treatment; (5) Voluntary signature of informed consent and willingness to be followed up; (6) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 5. Efficiency and safety of anti-toxoplasma regimens in HIV-infected patients with toxoplasma encephalopathy: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Toxoplasma gondii Encephalitis was clinically diagnosed; (4) Voluntary signature of informed consent and willingness to be followed up; (5) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 6. Timing of antiretroviral therapy for HIV-infected patients with toxoplasmic encephalitis: a multi-center prospective randomized controlled trial (1) 18-65 years old; (2) HIV-1 antibody was detected by ELISA and confirmed by Western Blot method; (3) Toxoplasma gondii Encephalitis was clinically diagnosed; (4) Have not received any antiretroviral treatment; (5) Voluntary signature of informed consent and willingness to be followed up; (6) Researchers believe that the condition of the subjects does not affect the evaluation and completion of the experiment. 7. Efficiency and safety of anti-pneumocystis regimens in HIV-infected patients with moderate-to-severe pneumocystis pneumonia: a multi-center prospective cohort study

Exclusion criteria

Exclusion criteria: 1. Impact of cryptococcal antigen screening and antifungal interventions on incidence of cryptococcal meningitis in HIV-infected patients: a multicenter prospective randomized controlled trial (1) Seriously allergic or intolerant to fluconazole; (2) Hemoglobin 2 times reference level upper limit, serum creatinine >1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin >2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (3) Patients who have been diagnosed or are currently diagnosed with cryptococcal meningitis; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals. 2. Management strategies of high intracranial pressures in HIV-infected patients with cryptococcal meningitis: a multicenter prospective cohort study (1) Hemoglobin 2 times reference level upper limit, serum creatinine>1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin >2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (2) Combined with other diseases affecting efficacy and prognosis; (3) Concomitant other opportunistic infections and unstable conditions; (4) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (5) Women during pregnancy and lactation; (6) Patients with severe mental illness; (7) Intravenous drug addict; (8) Non-Chinese nationals. 3. Efficiency and safety of antifungal regimens in HIV-infected patients with cryptococcal meningitis: a multi-center prospective randomized controlled trial (1) Seriously allergic or intolerant to amphotericin B deoxycholate, fluconazole, voriconazole, flucytosine, etc.; (2) Patient has previously been diagnosed with cryptococcal meningitis and has been treated with normative cryptococcosis in the past month; (3) Hemoglobin 2 times reference level upper limit, serum creatinine>1.5 Double reference level upper limit, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase>5 times reference level upper limit, total bilirubin>2 times reference level upper limit, serum creatine phosphokinase (CK) >2 times reference level upper limit; (4) Patients are regulating the use of antifungal drugs; (5) Combined with other diseases affecting efficacy and prognosis; (6) Concomitant other opportunistic infections and unstable conditions; (7) Have serious heart, brain, lung, kidney, tumor and other basic diseases; (8) Women during pregnancy and lactation; (9) Patients with severe mental illness; (10) Intravenous drug addict; (11) Non-Chinese nationals.

Design outcomes

Primary

MeasureTime frame
Incidence of cryptococcal meningitis;Cryptococcal antigen conversion rate;Mortality of cryptococcal meningitis;Intracranial pressure;Response rate of Toxoplasmic encephalitis;Mortality of Toxoplasmic encephalitis;Response rate of PCP;Mortality of PCP;Mortality of CMV;Response rate of treatment for CMV;Eye symptom;

Secondary

MeasureTime frame
Cryptococcal antigen titer;Disability rate of cryptococcal meningitis;Cerebrospinal fluid biochemical routine;Incidence of IRIS;

Countries

China

Contacts

Public ContactYaokai Chen

Chongqing Public Health Medical Center

yaokaichen@hotmail.com+86 13838352995

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026