You have been invited to participate in a research study for Kaletra® (lopinavir/ritonavir), which has been approved in a tablet formulation by the Therapeutic Goods Administration (TGA) to treat Human Immunodeficiency Disease type-1 (HIV-1). Before you decide whether or not you want to participate in this study, you should know what the purpose of this study is, what the potential benefits and risks of participating in the study are and what is expected of you as a study participant.
Purpose
Participants for this study are chosen because they are HIV-1 positive and need to change their therapy. The primary purpose of this research study is to compare the safety, tolerability and antiviral activity of once-daily and twice-daily dosing of the lopinavir/ritonavir tablet formulation in subjects with detectable viral load while receiving their current antiretroviral therapy.
The other purpose of this study is to characterise the development of resistance in daily and twice-daily dosing of the lopinavir/ritonavir tablet in antiretroviral-experienced subjects.
General Information
This study is sponsored by Abbott Australasia Pty Ltd. Approximately 600 HIV-1 positive subjects, aged 18 and older, with detectable viral load while receiving their current antiretroviral therapy will participate in this study at approximately 200 research centers around the world. Participants will be in this study for approximately 48 weeks. This is an open-label study. This means that the patient, the study doctor/study staff and the study sponsor, Abbott, will know which medications the patient will be receiving.
There are two treatment groups of lopinavir/ritonavir that are being tested in this study. One group will take study drug daily and one group that will take study drug twice-daily. The daily dosing is experimental. If you qualify to participate in the study, you will be selected by chance (like the flip of a coin) and will have a 1 out of 2 chance of being in the daily or twice-daily grouping. The patient will remain in the same group for the duration of the study.
About the Study Medication
The study drug used in this study is approved by the TGA for the treatment of HIV-1 infection. Anti-HIV-1 medications should be used in combination with other anti-HIV-1 medications to maximise their effectiveness. Therefore, it is important that this medication should not be taken alone but must be taken in combination with other medications.
Abbott will only provide lopinavir/ritonavir throughout the study. Lopinavir/ritonavir is a protease inhibitor. Protease inhibitors work by causing the HIV-1 virus to make copies of itself that are not able to infect other cells. Other protease inhibitors include ritonavir (Norvir®), amprenavir (Agenerase®), indinavir (Crixivan®), nelfinavir (Viracept®), atazanavir (Reyataz®), saquinavir (Fortovase®, Invirase®) and fosamprenavir (Telzir®).
The study doctor will select the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for the participant to take with lopinavir/ritonavir during the study. NRTIs treat HIV-1 infection by preventing HIV-1 from making copies of itself. In some situations, the study doctor may make changes to the participants NRTIs based on the following factors:
- the HIV-1 virus levels in participants blood
- the participants ability to tolerate the study medications
- the participants treatment history
- the participants test results of whether he/she has HIV-1 virus with possible resistance
Information on the study provided herein is extracted from the consent form approved by the relevant Ethics Board– potential participants in the study should obtain the approved consent form for their review.
PLEASE SEE ALSO CLINICAL TRIALS OVERVIEW
For more information, or a copy of the Consent Form, please email us at trials@holdsworthhouse.com.au
Or call the trials team on (02) 9331 7228
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