Low dose of trimethoprim-sulfamethoxazole for treatment pneumocystis pneumonia in patient with HIV

Low dose of trimethoprim-sulfamethoxazole for moderate to severe PCP pneumonia in HIV patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250222003

Enrollment

140

Registered

2025-02-22

Start date

2025-03-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Pneumocystis pneumonia in people living with HIV pneumonia, pneumocystis human immunodeficiency virus Trimethoprim, Sulfamethoxazole Drug Combination low dose

Interventions

1 Administer 10-12 mg/kg/day of TMP based on actual body weight or adjusted body weight if the actual weight is greater than 120% of the ideal body weight 2 Oral or intravenous TMP/SMX (80/400 mg) sho

Experimental Drug,Active Comparator Drug

Low dose TMP-SMX,Standard dose TMP-SMX

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Diagnosed with pneumocystis pneumonia 3. Individuals living with HIV infection 4. CD4 count of less than 200 cells/uL 5. Enrolled within 72 hours after the initial diagnosis of pneumocystis pneumonia

Exclusion criteria

Exclusion criteria: 1. Allergy to TMP-SMX 2. History of receiving TMP-SMX for pneumocystis pneumonia prophylaxis for more than 28 days 3. Pregnancy or breastfeeding 4. Diagnosis of G6PD deficiency or porphyria 5. Elevated liver enzymes greater than five times the normal limit 6. Creatinine clearance less than 15 mL/min/1.73 m2

Design outcomes

Primary

Measure	Time frame
Treatment success among participant without side effect 21 day Clinical success after complete treatment will be evaluated through clinical assessment, radiographic imaging, and oxygenation levels.	—

Secondary

Measure	Time frame
Treatment success 21 day Clinical success after complete treatment, participants experiencing side effects that necessitate a switch or an adjustment in the dose of TMP-SMX will be classified as treatment failures.,Mortality rate 21 day count,Need of oxygen supplement day 7 count,Adverse event related with TMP-SMX 21 day CTCAE grading,Factor associated with renal toxicity 21 day Multivariate analysis compare baseline characteristic, co-infection, treatment regimen,Adverse event need to switching or adjusted dose 21 day count	—

Measure

Time frame

Treatment success 21 day Clinical success after complete treatment, participants experiencing side effects that necessitate a switch or an adjustment in the dose of TMP-SMX will be classified as treatment failures.,Mortality rate 21 day count,Need of oxygen supplement day 7 count,Adverse event related with TMP-SMX 21 day CTCAE grading,Factor associated with renal toxicity 21 day Multivariate analysis compare baseline characteristic, co-infection, treatment regimen,Adverse event need to switching or adjusted dose 21 day count

—

Countries

Thailand

Contacts

Public ContactNatthakit Chavapradit

Bhumibol Adulyadej Hospital

natthakit.c@chula.ac.th6625347340

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026