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Important Information

Please note, we need you to ….
  • Read the important documents for this study
  • If you are interested, look at the dates that this study is being run (cohort visit planners) and  reply to our email (don’t re-register online) to let us know which cohort(s) you are available for
  • We will ring you to check your suitability and provide further information about the study
  • We will make you a screening appointment at NZCR Auckland. You will need to attend at the scheduled time if you wish to take part in the study

Study Information

New Zealand Clinical Research is trialling an experimental drug to observe the safety, tolerability and how the drug is broken down and eliminated from the body. If this study is successful, this experimental drug may potentially be used for the treatment of HIV type 1 (human immunodeficiency virus). HIV is a virus that attacks the immune system, the body’s defence, against diseases. Chronic infection of HIV can lead to an impaired immune system which leads to Acquired Immunodeficiency Syndrome (AIDS).

Typically, HIV-1 infection is treated with a combination of oral ARV (antiretroviral) drugs which delay disease progression. These drugs generally need to be taken every day and require strict adherence to be optimally effective.  This drug is being tested as it is hoped that it can provide an alternative treatment, being administered on a less frequent basis.

This study will test an experimental drug, which is being developed as a potential antiviral treatment for HIV-1. The drug has been approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) in a different formulation than what is being investigated in this study.  Thus, the drug used in this study is an investigational product because it has not been approved by the New Zealand MedSafe or other drug regulatory authorities.

Study Candidates

  • Healthy Males and Females
    • Age 18 – 55
    • BMI less than 35 kg/m2
    • Non – Smokers or have stopped more than 6 weeks ago
    • Not currently taking any medications

What is Involved?

Study Visits: 15 night stay

Outpatient visits: 17 visits + 4 phone calls

Reimbursement: $10,000 (less tax)

Pre-screening Form

Personal details

Please provide your name, email and phone number so we can contact you

Medical questions

Have you had any covid symptoms in the last 4 weeks or been in isolation?
Have you previously participated in a study with NZCR or any other organisation? Give details or leave blank if no
This study requires the use of contraception during the study. If you are in a hetereosexual relationship both partners must agree to use contraception (condoms for males | IUD, birth control or another approved form for females). Are you currently using 2 forms of contraception?
Have you received blood or plasma in the last 90 days? If yes please provide details
The study does not accept any current smokers. Have you used any nicotine or tobacco containing products in the last 3 months?
Any history or current autoimmune disorders? Are you being treated with any immunosuppressive medication? - For e.g., psoriasis, rheumatoid arthritis, Crohn’s disease, or ulcerative colitis etc
Are you pre-diabetic or do you have any history of diabetes?
Any history of abnormal liver or kidney conditions?
Do you have any significant heart disease or heart related conditions/abnormalities? Do you have any family history of heart conditions?
Do you have any history of allergies, asthma, hay fever, food allergies etc that you are aware of?
Any significant history of Acid reflux or peptic ulcers?
Do you have any history of clinically significant acute systemic infection and/or antibiotic treatment within 28 days?
Have you been sick in the last 30 days?
Do you have any history of medical conditions relating to:(Required)
If you have none, please select the last option.
Have you taken any prescription, vitamins, supplements, pharmacy medication or over the counter medications in the last 28 days? Please include any Vaccines in the last 3 months
Have you looked at the study dates and are okay to come in those days? Indicate which group/s you are available for. This means having flexibility for more than one group increases your chances of being accepted into a group.
Pre-screening form policy(Required)
I understand that by submitting this form, NZCR will use the information for pre-screening purposes for this study. This information may be recorded on your profile to allow us to improve our process when screening you for a future study. All information provided is confidential. I also understand that by submitting this form, I will be receiving emails, texts or calls about this study. For more information, please refer to the Privacy Policy (https://www.nzcr.co.nz/privacy-policy/).