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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000258358

Acronym

BVM 204

Enrollment

Registered

2008-05-21

Start date

2008-04-18

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 optimised background regiment). Total planned duration of the study is approximately 7 weeks minimum to 81 weeks maximum.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- documented HIV-1-infection - a CD4+-lymphocyte count =100 cells/mm3 - a screening plasma HIV-1 RNA value of 2,000 – 500,000 copies/mL. - treatment-experienced patients must have documented evidence of genotypic resistance in their medical records (at screening) or have a resistance-associated primary mutation at screening by genotype to at least one approved ARV (Anti-retroviral) drug identified on the most recent IAS-USA l(international AIDS society USA) ist of resistance drug mutations - For treatment-experienced patients: be receiving an antiretroviral therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to initial screening. Note: A washout period of at least 3 days prior to Day 1 of dosing is required. - treatment-naïve patients: no previous antiretroviral treatment. - Be able to receive an optimized background regimen

Exclusion criteria

- Current opportunistic infection characteristic of AIDS that is diagnosed within 30 days or is poorly controlled. - unable to comply with the dosing schedule and protocol evaluations. - with malabsorption syndromes affecting drug absorption - A history of seizures or current administration of prophylactic anti-seizure medications. - history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA). - must have laboratory parameters within pre-specified limits. - Patients who have received treatment with immunomodulating agents within 4 weeks prior to the first dose of study drug. - Patients who have ever received an HIV immunotherapeutic vaccine. - Recent use of any recreational drugs (except marijuana), or positive results from a urine screen for substances of abuse - Bupropion-containing products require at least a 14-day washout period. - Rifampin or other rifamycin products require at least a 28-day washout period.

Outcome results