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Evaluating the Necessity and Safety of Co-trimoxazole Prophylaxis in People Living with HIV Initiating Rapid ART with Low CD4 Counts: A Multicenter Randomized Controlled Trial

Evaluating the Necessity and Safety of Co-trimoxazole Prophylaxis in People Living with HIV Initiating Rapid ART with Low CD4 Counts: A Multicenter Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260116002
Enrollment
64
Registered
2026-01-16
Start date
2025-12-22
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

HIV infection with CD4 count below 200 cells per microliter and risk of Pneumocystis jirovecii pneumonia HIV Infections

Interventions

no prophylactic medication and will start rapid ART within 2 weeks ,oral TMP/SMX at a dose of 80 mg trimethoprim and 400 mg sulfamethoxazole once daily and will start rapid ART within 2 weeks
No prophylaxis ,Oral TMP/SMX

Sponsors

Department of Medicine, Phramongkutklao Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Confirmed HIV infection 2 CD4 count below 200 cells per microliter or CD4 percentage below 14 3 Start of ART within 14 days 4 No clinical evidence of PJP

Exclusion criteria

Exclusion criteria: 1 Allergy to TMP-SMX or sulfonamides 2 Pregnant or breastfeeding 3 Hemoglobin below 7 g per dL 4 Platelet count below 75 billion per liter -Neutrophil count below 0.75 billion per liter -Serum potassium above 5.0 mEq per L -Acute liver failure or Child Pugh class C score 10 or higher -TB meningitis or cryptococcal meningitis -Use of TMP-SMX, clindamycin, primaquine, or dapsone

Design outcomes

Primary

MeasureTime frame
Composite outcome of adverse drug events and PJP-associated mortality 24 weeks Relative risk

Secondary

MeasureTime frame
PJP incidence 24 weeks Relative risk,Change in CD4 count 24 weeks Mean different ,HIV viral load suppression 24 weeks Relative risk

Countries

Thailand

Contacts

Public ContactOnrujee Thichina

Phramongkutklao Hospital

beewhityou@gmail.com027633278

Outcome results

None listed

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