Can a standard HIV pill rescue those who got infected on Long-Acting PrEP?
NCT ID NCT06485154
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a daily combination pill (TLD) as first-line HIV treatment for 100 people who became infected with HIV despite receiving long-acting cabotegravir PrEP in the past year. Researchers will check if the pill can suppress the virus to undetectable levels after 6 months. The goal is to find a reliable treatment option for this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tenofovir, Lamivudine, and Dolutegravir (TLD) combination pill
- What this could lead to
- If successful, this could confirm that a standard daily HIV pill works well for people who get infected despite using long-acting PrEP, offering a reliable treatment option.
- What could go wrong
- This is a small, single-arm study with only 100 participants, so results may not apply to everyone. Drug resistance from prior PrEP use could reduce effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female. 2. Age ≥ 15 years, inclusive, at the time of signing the informed consent. 3. Body weight ≥ 35 kg. 4. Confirmed HIV-1 infection. 5. Exposure to at least one dose of CAB-LA PrEP in the past 12 months. 6. Consent to initiation of ART. 7. Estimated glomerular filtration rate (eGFR) \> 50 min/mL Exclusion Criteria: 1. Any previous exposure to DTG. 2. Concurrent or recent (within the preceding 3 months) participation in another interventional clinical trial with a compound likely to interfere with any of the investigational medicinal products. 3. Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds. 4. Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study: 1. tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy; 2. anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin); 3. herbal products (e.g., St John's Wort). 5. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and/or protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history. 6. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results. This including inability or an unwillingness to be followed up for the study period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Africa Health Research Institute (AHRI)
RECRUITINGDurban, KwaZulu-Natal, 3935, South Africa
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Desmond Tutu Health Foundation
RECRUITINGCape Town, Western Cape, 7925, South Africa
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Ezintsha, a division of Wits Health Consortium
RECRUITINGJohannesburg, Gauteng, 2193, South Africa
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