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.

Myriad Pharmaceuticals Inc.0 个研究点目标入组 32 人开始时间: 2008年5月21日最近更新: 2020年1月13日

试验速览

暂无简介。

•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

•- 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.

发起方

Myriad Pharmaceuticals Inc.