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.
- Conditions
- HIV-1Infection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12608000258358
- Lead Sponsor
- Myriad Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate antiretroviral activity and safety administered as momotherapy for 14 days. Primary efficacy endpoint is defined as the mean change in viral load (HIV-1 Ribonucleic acid (RNA) log10 copies/mL0 from baseline at day 15).[At screening, baseline, day 1, 3, 7, 10 and 15.]
- Secondary Outcome Measures
Name Time Method