ActivePhase 2ACTRN12608000258358

Clinical study to assess the efficacy and safety of a new antiretroviral drug (MPC-4326) in patients with Human immunodeficiency virus-1 (HIV-1) infection over a period of 14 days to 72 weeks.

title: A Phase II multicenter, open-label, randomized, parallel group, study of MPC-4326 in HIV-1 positive patients to evaluate the safety, efficacy, and pharmacokinetics of MPC-4326 administered as monotherapy for 14 days and as part of an optimized background regimen for up to 72 weeks.


Sponsor

Myriad Pharmaceuticals Inc.

Enrollment

32 participants

Start Date

Apr 18, 2008

Study Type

Interventional

Conditions

Summary

The main purpose of this research study is to evaluate the antiretroviral (how effective the drug is at reducing the amount of HIV in the blood) activity of two different doses of MPC-4326 in HIV-1 positive participants and what, if any, side effects there may be through 14 days of dosing. This study will also evaluate the antiretroviral activity and safety of bevirimat in participants who continue treatment with bevirimat as part of combination highly active antiretroviral therapy for up to 72 weeks. We also want to know how much of the drug gets into your blood stream following oral administration. We are asking participants who will start their treatment for the first time (so called naïve (exposed to treatment for the first time) participants) and who are already on treatment (treatment experienced participants) to participate. If you choose to participate in this study and do not intend to continue MPC-4326 treatment past 14 days, you should not expect any medical benefits from taking part in this study and it is even possible that your HIV could worsen during the study. The potential benefit to society may be information gained on the safety and effectiveness of the study treatment for patients in the future. However, if you choose to participate in this study and intend to continue MPC-4326 treatment past 14 days should your viral load reduction in those first 14 days be at least two-thirds or 66.6% as compared with your viral load value at baseline, then you may have medical benefits from taking part in this study. These possible benefits include a persistent viral load reduction and an improvement in the CD4 count (a blood marker of immune system health) that may occur. As this is an experimental medication, the likelihood of these benefits occurring for you is not yet known.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical study tests a new antiretroviral drug called MPC-4326 in people living with HIV-1 infection. The study runs from 14 days to 72 weeks and is open to adults aged 18 or older, including both treatment-experienced patients whose current medications are not fully controlling the virus and those who have never been treated before.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

MPC-4326 (code name) 200mg BID (twice daily) and 300mg BID doses of MPC-4326(tablets). Total duration of bevirimat treatment is 14 days minimum (monothereapy) to 72 weeks maximum (together with an opt

MPC-4326 (code name) 200mg BID (twice daily) and 300mg BID doses of MPC-4326(tablets). Total duration of bevirimat treatment is 14 days minimum (monothereapy) to 72 weeks maximum (together with an optimised background regiment). Total planned duration of the study is approximately 7 weeks minimum to 81 weeks maximum.


Locations(3)

New Zealand

Belgium

Poland

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ACTRN12608000258358


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