CALYPSO

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 for the infection of Human Immunodeficiency Virus 1 (HIV-1) in the future.

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 experimental 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 Visits: 15 night stay

Outpatient visits: 22 visits + 11 phone calls

Reimbursement: $13,000 (less tax)