Phase 4 HIV and AIDS Trial, Recruiting NCT06485154 Sponsor: University of Witwatersrand, South Africa Condition: HIV and AIDS
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Phase 4 HIV and AIDS Trial, Recruiting

NCT06485154
Recruiting Phase 4

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 of any gender
  • People aged 15 years or older at the time of signing the consent form
  • People who weigh at least 35 kg
  • People who have a confirmed HIV-1 diagnosis
  • People who have received at least one dose of long-acting cabotegravir (CAB-LA) as HIV prevention (PrEP) in the past 12 months
  • People who agree to start HIV treatment (ART)
  • People whose kidneys are functioning above a certain level, based on a blood test result (confirm with trial site)

Who may not be able to join:

  • People who have previously taken the HIV medication dolutegravir (DTG)
  • People who are currently taking part in, or have taken part in within the last 3 months, another clinical trial involving a medication that could interfere with this study
  • People who have a known allergy or medical reason to avoid any of the medications used in this trial
  • People who are currently taking, or have taken within the past 28 days, certain tuberculosis medications (such as rifampicin, rifapentine, or rifabutin — not including isoniazid prevention therapy), certain anti-seizure medications (such as carbamazepine, oxcarbazepine, phenobarbital, or phenytoin), or herbal products such as St John's Wort — unless those medications can be safely stopped for the duration of the study
  • People who have a medical or surgical condition that could significantly affect how medications are absorbed or processed in the body, or that could affect their safety or ability to follow the study schedule (the trial doctor makes this assessment based on medical history)
  • People who the trial doctor believes are unlikely to be able to follow the study requirements, or who would be unable or unwilling to attend follow-up visits for the full study period

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 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: FRANCOIS WD VENTER, PhD, Ezintsha, a division of Wits Health Consortium

Phone: 0110844961

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 4
Sponsor
University of Witwatersrand, South Africa
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

To evaluate the efficacy of TLD as first-line antiretroviral therapy (ART) in participants with HIV-1 infection and CAB-LA PrEP exposure in the past 12 months

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: 28 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