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The Late Presenter Treatment Optimisation Study (LAPTOP)
EU CTIS ID: 2023-505167-36-00
What this study is testing
To demonstrate an Integrase Inhibitor containing regimen is no better than a boosted Protease Inhibitor regimen in patients with advanced HIV infection. If the integrase inhibitor regimen is proved to be no better then, we would like to demonstrate whether the Integrase inhibitor regime is superior to the Protease Inhibitor containing regimen.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements
- ≥ 18 years
- HIV-1 infected AIDS except active tuberculosis (TB) or cryptococcal meningitis with any CD4 cell count, or; severe bacterial infection (BI) and must have a CD4 cell count < 200/μL within 28 days prior to study entry, or; any symptoms or no symptoms with CD4 cell count < 100/μL within 28 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL, or; currently being treated for opportunistic infections (OI)
- Have an entry HIV viral load > 1000 copies/mL
- Able to take oral medications
- ART-naïve prior to study enrolment
You likely can't join if
- Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours
- Any investigational drug within 30 days prior to the study drug administration.
- Patients with severe (Child Pugh class C) hepatic impairment.
- Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
- Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi’s sarcoma) or lymphoma.
- Current or anticipated use of contraindicated medications (see Summary of Product Characteristics (SmPC) for Symtuza® and Biktarvy®) or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study).
See the full eligibility criteria
- Ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements
- ≥ 18 years
- HIV-1 infected AIDS except active tuberculosis (TB) or cryptococcal meningitis with any CD4 cell count, or; severe bacterial infection (BI) and must have a CD4 cell count < 200/μL within 28 days prior to study entry, or; any symptoms or no symptoms with CD4 cell count < 100/μL within 28 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL, or; currently being treated for opportunistic infections (OI)
- Have an entry HIV viral load > 1000 copies/mL
- Able to take oral medications
- ART-naïve prior to study enrolment
- Willing to use acceptable methods of contraception
- Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours
- Any investigational drug within 30 days prior to the study drug administration.
- Patients with severe (Child Pugh class C) hepatic impairment.
- Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
- Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi’s sarcoma) or lymphoma.
- Current or anticipated use of contraindicated medications (see Summary of Product Characteristics (SmPC) for Symtuza® and Biktarvy®) or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study).
- Known resistance to the components of study medications
- History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR <30 mL/min; hepatic transaminases (AST and ALT) > 5 x upper limit of normal (ULN); or, platelet count <50,000.
- Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.
- Cryptococcal meningitis or active TB, or current or expected treatment requiring Rifampicin or Rifabutin (patients with expected latent TB will have a TB test (IGRAs e.g. ELISPOT, QuantiFERON etc.) at their screening visit).
- History or presence of allergy to the study drugs or their components, or drugs of their class.
- Using any concomitant therapy disallowed as per the product labelling for the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. 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 EU CTIS; the study team decides eligibility.