An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease -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: 20.0 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-003481-13-ES
- Lead Sponsor
- EAT ID Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 440
1. The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements.
2. Male or non-pregnant, non-lactating females.
3. Age = 18 years.
4. Has documented, untreated HIV-1 infection with either:
a) AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3).
Or
b) Severe bacterial infection (BI)† and must have a CD4 cell count < 200/µl within 30 days prior to study entry.
Or
c) Are asymptomatic with CD4 cell count < 100/µL within 30 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL.
Or
d) Currently receiving treatment for OI‡. i. Subjects with other serious OIs, including other AIDS-defining and AIDS-related OIs for which appropriate therapy other than ART exists are eligible, but Investigator approval must be obtained. ii. Current OI treatment must have been started = 14 days prior to study entry, but can have been discontinued prior to study entry.
5. Have the ability to take oral medications.
6. If female and of childbearing potential, is using effective birth control methods (see Appendix 7) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the last dose of study medication. Note: Non-childbearing potential is defined as either post-menopausal (12 months of spontaneous amenorrhoea and =45 years) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
7. If a heterosexually active male, is using effective birth control methods and is willing to continue practising these birth control methods during the trial and for at least 30 days after the last dose of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
1. Any ARV prior to study entry.
2. Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi’s sarcoma) or lymphoma.
3. Current or anticipated use of contraindicated medications (see Summary of Product Characteristics (SmPC) for Symtuza® and IB for B/F/TAF) 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).
4. Known resistance to the components of study medications (see section 6.1.3 for more details).
5. 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.
6. Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.
7. 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).
8. History or presence of allergy to the study drugs or their components, or drugs of their class.
9. Using any concomitant therapy disallowed as per the reference safety information (RSI) and product labelling for the study drugs.
10. Any investigational drug within 30 days prior to the study drug administration.
11. Patients with severe (Child Pugh class C) hepatic impairment.
12. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
13. Females of childbearing potential and heterosexually active males must be willing to use a highly effective method of contraception. See Appendix 7 for further details. Such methods include: • combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: ? oral ? intravaginal ? transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation ? oral ? injectable ? implantable • intrauterine device (IUD) • intrauterine hormone-releasing system (IUS) • bilateral tubal occlusion • vasectomised partner • sexual abstinence (with male partners)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method