Phase 3 HIV and AIDS Trial, Recruiting NCT04851015 Sponsor: Todd C. Lee MD MPH FIDSA Condition: HIV and AIDS
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Phase 3 HIV and AIDS Trial, Recruiting

NCT04851015
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older
  • People whose immune system is weakened — this includes conditions or treatments such as HIV, organ transplants, certain cancers (including blood cancers), bone marrow transplants, autoimmune or systemic diseases, chemotherapy, long-term steroid use, immunosuppressive medications, or inherited immune deficiencies
  • People who have attended a day hospital or emergency department, or who have been admitted to hospital
  • People who have a confirmed or likely diagnosis of a lung infection called PCP (Pneumocystis pneumonia), based on specific diagnostic criteria used by the trial

Who may not be able to join:

  • People who have had a serious allergic or harmful reaction to the antibiotic TMP-SMX (also known as trimethoprim-sulfamethoxazole), any sulfa-based drug, or any ingredient in the medication being studied
  • People who have been consistently taking TMP-SMX as a preventive treatment for PCP for 4 weeks or more at the time of enrolment
  • People who have already received more than 96 hours (4 days) of any treatment for PCP before joining the trial
  • People with significant liver problems, specifically where a liver enzyme called alanine aminotransferase is measured at 5 or more times the normal upper limit
  • People who have a condition called G6PD deficiency (a genetic enzyme disorder affecting red blood cells)
  • People who have a condition called porphyria (a group of disorders affecting the nervous system or skin)
  • People who are known to be pregnant or breastfeeding (as noted by Health Canada guidelines)
  • People who are unable to give informed consent themselves and do not have a healthcare proxy available to do so on their behalf; people who have declined to give consent; or people who cannot be reliably contacted outside of hospital (for example, by phone, email, or text message
  • People who have previously taken part in this trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Emily G McDonald, MD MSc, Research Institute of the McGill University Health Centre

Phone: 514-934-1934

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Todd C. Lee MD MPH FIDSA
Registry
ClinicalTrials.gov
Start date
28 November 2025
Est. completion
30 September 2030

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Hierarchical composite outcome

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov