BridgeMD
New treatment option for HIV Prevention
Official title Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
ClinicalTrials.gov ID: NCT06485154
What this study is testing
What is TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir?
TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv prevention.
Also referred to as Acriptega.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months. Participants will be followed up for a period of 12 months from enrolment.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Male or female.
- Age ≥ 15 years, inclusive, at the time of signing the informed consent.
- Body weight ≥ 35 kg.
- Confirmed HIV-1 infection.
- Exposure to at least one dose of CAB-LA PrEP in the past 12 months.
You likely can't join if
- Any previous exposure to DTG.
- Concurrent or recent (within the preceding 3 months) participation in another treatment clinical trial with a compound likely to interfere with any...
- Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.
- 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:
- tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;
- anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
See the full eligibility criteria
- Male or female.
- Age ≥ 15 years, inclusive, at the time of signing the informed consent.
- Body weight ≥ 35 kg.
- Confirmed HIV-1 infection.
- Exposure to at least one dose of CAB-LA PrEP in the past 12 months.
- Consent to initiation of ART.
- Estimated glomerular filtration rate (eGFR) \> 50 min/mL
- Any previous exposure to DTG.
- Concurrent or recent (within the preceding 3 months) participation in another treatment clinical trial with a compound likely to interfere with any of the investigational medicinal products.
- Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.
- 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:
- tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;
- anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
- herbal products (e.g., St John's Wort).
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Johannesburg, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
- Cape Town, Western Cape, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Johannesburg, Gauteng, South Africa; Durban, KwaZulu-Natal, South Africa; Cape Town, Western Cape, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.