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Timing of antiretroviral therapy for AIDS patients with toxoplasma encephalitis: a multicenter prospective randomized controlled trial

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
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031257
Enrollment
Unknown
Registered
2020-03-26
Start date
2019-02-01
Completion date
Unknown
Last updated
2020-03-30

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

Conditions

AIDS-associated toxoplasma encephalitis

Interventions

the early ART initiation arm:initial ART =14 days after TE treatment
the deferred ART initiation arm:initial ART >14 days after TE treatment

Sponsors

Chongqing Public Health Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Adult (defined as >= 18 years of age); (2) Confirmed HIV infection; (3) Diagnosed with TE; (4) ART-native; (5) Willingness to give an informed consent.

Exclusion criteria

Exclusion criteria: (1) Allergic or intolerant to ART drugs; (2) Hemoglobin (Hb) 2 x UNL, serum creatinine (Scr) >1.5 x UNL, aspartate aminotransferase (AST) /alanine aminotransferase (ALT) /alkaline phosphatase (ALP) > 5 times of UNL, total bilirubin (TB) >2 x UNL, serum creatine phosphokinase (CK) > 2 x UNL; (3) Pregnancy or breast-feeding; (4) Severe cardiovascular disease, liver disease, kidney disease, lung disease or other diseases that may reduce patient compliance; (5) Severe mental illness; (6) Patients with intravenous recreational drug use; (7) Non-Chinese nationality.

Design outcomes

Primary

MeasureTime frame
the overall mortality at week 48;

Secondary

MeasureTime frame
CD4+ cell counts from baseline to week 48;the rate of virologic suppression at week 48;the incidence of TE-IRIS;the incidence of AEs;

Countries

China

Contacts

Public ContactYaokai Chen

Chongqing Public Health Medical Center

yaokaichen@hotmail.com+86 023-65481658

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026