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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Hanna
Box
h.box@imperial.ac.uk
Stephen
Fletcher
rio_trial@imperial.ac.uk
Prof
Sarah
Fidler
s.fidler@imperial.ac.uk
Stephen
Fletcher
rio_trial@imperial.ac.uk
Dean
Leighton
dean.leighton@nihr.ac.uk
Maathini
Balachandran
m.balachandran@imperial.ac.uk
Human immunodeficiency virus [HIV] disease
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Antiretroviral therapy (ART) for the treatment of HIV infection has dramatically improved survival and is highly effective at preventing disease progression to AIDS and onward transmission. However, two key problems remain. The first is that ART is not a cure for HIV infection as it is unable to eradicate a reservoir of persisting, latently infected cells. These are predominantly CD4+ T cells which contain an integrated proviral genome which is transcriptionally-silenced; accordingly these latently infected cells do not produce any virions or viral proteins until they are activated. Eradicating this reservoir is key to curing HIV infection.
The second problem is that ART needs to be taken daily for the entirety of a person’s life. This can lead to treatment fatigue, poor adherence and drug resistance, as well as risks of drug-related long-term toxicities. As a result of these challenges, solutions are being sought to improve how therapy is provided. This has particular relevance for sub-Saharan Africa where ensuring ART drug supplies and helping with adherence requires enormous resources. The additional implications for long-acting therapies to prevent mother-to-child transmission and to help with groups that traditionally have adherence difficulties (e.g. children and adolescents) are potentially game-changing for HIV care delivery. Long-acting broadly neutralising antibodies (bNAbs) targeted against the HIV Env protein are of interest in solving both of these problems.
Individuals who are otherwise healthy and who commenced ART close to the time of HIV acquisition (primary HIV infection, PHI) have the best chance to achieve a period of post-treatment viral control, as the size of the HIV reservoir is small and the immune system is normalised. This study will test the use of bNAbs in participants with treated primary HIV infection (PHI), to see if their use can confer viral suppression in the absence of ART and even induce a period of post-treatment viral control, or ‘remission’, when off all therapies.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Not Specified;
You can take part if:
You may not be able to take part if:
Exclusion criteria • Previous ischaemic heart disease (ST or non-ST myocardial infarction, Q-risk > 20, stable angina, unstable angina, stroke) • Any current or past history of malignancy, excluding squamous cell skin cancers • Concurrent opportunistic infection or other comorbidity or comorbidity likely to occur during the trial e.g. malabsorption syndromes, autoimmune disease • Any contraindication to receipt of BHIVA recommended combination antiretrovirals • HTLV-1 co-infection • Current or planned systemic immunosuppressive therapy (inhaled or topical corticosteroids are allowed) • Participation in any other clinical trial of an experimental agent or any non-interventional study where additional blood draws are required; participation in an observational studies is permitted • History of anaphylaxis or severe adverse reaction to antibody infusions • Clinically significant abnormal blood test results at screening including a. Moderate to severe hepatic impairment as defined by Child-Pugh classification b. ALT > 5 x ULN c. eGFR < 60 d. uPCR > 30 mg/mmol e. INR > 1.5 • Physical examination findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination and/or vital signs that the investigator believes is a preclusion from enrolment into the study • Active alcohol or substance use that, in the Investigator’s opinion, will prevent adequate adherence with study requirements • Insufficient venous access that will allow scheduled blood draws as per protocol • Concern regarding likelihood of participant not taking precautions to prevent HIV transmission during treatment interruption period • Pregnancy or breastfeeding
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Stephen
Fletcher
rio_trial@imperial.ac.uk
Dean
Leighton
dean.leighton@nihr.ac.uk
Hanna
Box
h.box@imperial.ac.uk
Maathini
Balachandran
m.balachandran@imperial.ac.uk
Prof
Sarah
Fidler
s.fidler@imperial.ac.uk
Stephen
Fletcher
rio_trial@imperial.ac.uk
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by Bill & Melinda Gates Foundation .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 43714
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