The Late Presenter Treatment Optimisation Study (LAPTOP)
- Conditions
- Patients who present late on during their acquisition of the HIV-1(Human Immunodeficiency Virus)MedDRA version: 20.0Level: LLTClassification code: 10020192Term: HIV-1 Class: 10021881Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-505167-36-00
- Lead Sponsor
- EAT ID Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 447
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: 1. To investigate the incidence of the following clinical events; immunological and virological response, tolerability, resistance development, discontinuation of therapy due to tolerability, quality of life and Immune Reconstitution Inflammatory Syndrome (IRIS)., 2. To assess whether virological response is better predicted by next generation deep sequencing rather than the standard population sequencing currently performed.;Primary end point(s): Time to failure, as the first occurrence of specified virological or clinical reasons.
- Secondary Outcome Measures
Name Time Method