The Late Presenter Treatment Optimisation Study

  • STATUS
    Recruiting
  • End date
    Dec 23, 2021
  • participants needed
    440
  • sponsor
    NEAT ID Foundation
Updated on 23 January 2021
HIV Infection
tenofovir
emtricitabine
cobicistat
hiv viral load
protease
darunavir
integrase inhibitors
oophorectomy
opportunistic infection

Summary

The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'.

There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future.

The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV:

The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza.

The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy.

The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part.

In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters.

To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.

Description

The effectiveness of HIV antiretroviral therapy (ART) has consistently improved over the years. This is largely due to newer drugs having improved antiviral effectiveness and more tolerable side effect profiles; resulting in better viral suppression and improved treatment adherence. On the other hand, most recent clinical trials look at the effectiveness of ART in patients with less advanced disease. These patients usually suffer from less related diseases, drug-drug interactions, and other risks for treatment failure. Outside of these trials, the number of patients who present to clinic with a more developed advanced HIV infection, known as 'late presenters', remains high across Europe. Trials for these patients have tended to focus on the time of starting treatment and the management of infections.

Much less is known about which ART treatments perform best for these late presenting patients; particularly in terms of virus suppression, immune system recovery, side effects and improvement of AIDs related diseases. No specific drug combinations have been compared in appropriate clinical trials before, and the international guidelines for first line treatment judge all therapies as equal standard of care for these patients.

The investigators anticipate that Integrase inhibitor containing regimes may be better suited to patients with advanced disease, due to their beneficial side-effect profile and ability to rapidly decrease viral load levels. Therefore the investigators are conducting this clinical trial to compare an integrase inhibitor regime, against a protease inhibitor regime in patients with advanced HIV infection. The aim of the study is to demonstrate the non-inferiority of Biktarvy against Symtuza.

Patients will be recruited from sites across Europe, and randomized onto either arm of the study. After randomisation onto either treatment regime, patients will attend approximately 9 follow-up visits over the course of a year. During these visits, patients will be asked to complete two questionnaires, to assess their quality of life and HIV symptoms. They will also be asked to provide a number of blood samples. These samples are to ensure that the patient is not resistant to the study drug and that their disease is not worsening. Samples to test for study drug resistance will be shipped to a laboratory for analysis in the even that the patient experiences virological failure.

Biktarvy will be supplied from Gilead and Symtuza will be provided by Janssen Pharmaceuticals.

Details
Condition HIV/AIDS, HIV/AIDS, HIV/AIDS, HIV/AIDS, HIV/AIDS
Treatment Biktarvy, Symtuza
Clinical Study IdentifierNCT03696160
SponsorNEAT ID Foundation
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have HIV/AIDS?
Do you have any of these conditions: Do you have HIV/AIDS??
The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements
Male or non-pregnant, non-lactating females
Age 18 years
Has documented, untreated HIV-1 infection with either
AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3)
Or
\. Severe bacterial infection (BI) and must have a CD4 cell count < 200/l
within 30 days prior to study entry
Or
\. Are asymptomatic with CD4 cell count < 100/L within 30 days prior to study
entry and must have an entry HIV viral load > 1000 copies/mL
Or
\. Currently receiving treatment for opportunistic infection (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
\. Have the ability to take oral medications
\. 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
\. 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

Exclusion Criteria

Any antiretroviral prior to study entry
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 Investigator's Brochure (IB) for 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 (see section 6.1.3 for more details)
History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR (epidermal growth factor receptor) <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 tuberculosis (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 reference safety information (RSI) and product labelling for the study drugs
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
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
ii.intravaginal
iii.transdermal
b.progestogen-only hormonal contraception associated with inhibition of
ovulation
i.oral
ii. injectable
iii.implantable
c. intrauterine device (IUD)
d. intrauterine hormone-releasing system (IUS)
e. bilateral tubal occlusion
f. vasectomised partner
g. sexual abstinence (with male partners)
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