Patient/Clinical trials

HIV treatment has come a long way in a relatively short space of time. Much of this is thanks to people living with HIV who have participated in clinical trials and cohort studies. This enables individuals to contribute to the advancement of new treatments as well as promote understanding and develop new approaches when addressing issues around prevention, testing and diagnosis.

Clinical trials research how safe and effective a new drug is likely to be in protecting or boosting the immune system, and in treating and preventing infections.

In Scotland, most clinical trials take place in Lothian (Genito-Urinary Medicine (GUM) Clinic and Regional Infectious Disease Unit (RIDU)), and in Glasgow (Brownlee Centre). The Edinburgh trials include:

  • PARTNERS STUDY - an observational study in which HIV serodiscordant partnership will be followed over time, with 3-6 monthly reporting of transmission risk behaviour and HIV testing for the HIV negative partner.
  • Cranium - study to assess and analyze prevalence of positive screening for anxiety and/or depressive symptoms and neurocognitive function impairment in HIV positive indiviudals who are naive to ART.
  • Pfizer POEM - an Observational Study of the Safety of Maraviroc.
  • UK register of Seroconverters - An observational study of HIV infected persons in the UK for whom the time of HIV seroconversion is well-estimated. HIV positive test within a year of a documented HIV Negative test result is requirement to take part.
  • Neat Study - an open-label randomized two-year trial comparing two first line regimens in HIV-infected antiretroviral naïve subjects: daruvanir/r + tenofovir/emtricitabine vs. Darunavir/r + Raltegravir
  • Pfizer A5371022 Study - a comparative trial - travirine in combination with Darunavir/Ritonavir and a Nucleoside/NRTI. Documented resistance to NNRTI and a viral load greater than 500 is a requirment to take part.

Please contact the Research Team on ext. 0131 537 2873 or pager #6477 for further information or to discuss any potential recruits to studies.

What is involved?

Clinical trials must follow strict rules about how they are conducted, and who can and cannot participate. The Regulation of Clinical Trials

The clinical trial team must give you information on the purpose, duration, key contacts and any potential risks or benefits. If you consent to the trial, then you know the facts.

It is entirely up to you whether or not to take part in the trial or to sign the form.

Never feel pressurised into taking part in a new trial and don’t participate if you don’t want to take part. You have the right to withdraw from a trial at any time.

What are the benefits?

Medical research is advanced through medical trials. The benefits to you might include:

  • Early access to latest treatments before licensing
  • Expert medical care for the individual
  • Staff have wide experience of new treatments once licensed and widely available

What are the risks?

You might need to consider some risks in taking part in a trial:

  • The new trial drugs may not have any benefits and may be harmful
  • New drugs may have unpleasant side effects
  • Time commitment and travel to the study site

Questions to ask

If you decide that you want to participate these are some of the questions you might want to ask:

  • What is the trial for?
  • Are there any side effects?
  • What is the time commitment?
  • How will my confidentiality be protected?