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Efficacy and safety of anti-Toxoplasma treatment regimens for AIDS-infected patients: study protocol of a multi-center 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
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031277
Enrollment
Unknown
Registered
2020-03-26
Start date
2018-05-01
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

Group A:TMP-SMX (oral dose of 1.44g, every 8 hours) plus azithromycin (intravenous dose of 0.5g, once a day), for at least 6 weeks
Group B:Synergistic sulfonamides (oral dose of 1.44g, every 8 hours) plus clindamycin (intravenous dose of 0.6 g, every 6 hours), for at least 6 weeks.

Sponsors

Chongqing Public Health Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients will be included in our study if they meet the following criteria: (1) Aged 18 years or older; (2) Confirmed diagnosis of AIDS-associated toxoplasma encephalitis; (3) Willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: Patients will be excluded from our study if they have the following: (1) Allergic or intolerant to therapeutic medications; (2) Hemoglobin (Hb) 2 UNL, serum creatinine (Scr) >1.5 UNL, aspartate aminotransferase (AST) /alanine aminotransferase (ALT) /alkaline phosphatase (ALP) >5 UNL, total bilirubin (TB) >2 UNL, serum creatine phosphokinase (CK) >2 UNL; (3) Unstable severe concomitant diseases, opportunistic infections other than toxoplasmic encephalitis, or mental illnesses that may affect efficacy assessment or compliance; (4) Pregnant or breastfeeding women; (5) Intravenous recreational drug use; (6) Non-Chinese nationality.

Design outcomes

Primary

MeasureTime frame
clinical response rate;all-cause mortality;

Secondary

MeasureTime frame
clinical response rate;all-cause mortality;adverse events;

Countries

China

Contacts

Public ContactYao Kaichen

Chongqing Public Health Medical Center

yaokaichen@hotmail.com+86 13838352995

Outcome results

None listed

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