HIV-1 MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: RDEA806
Product Code: RDEA806
Pharmaceutical Form: Capsule*
INN or Proposed INN: NA
Current Sponsor code: RDEA806
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Ardea Biosciences Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Documented chronic HIV-1 infection 2. HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/ml (assayed by Roche Amplicor HIV-1 Monitor™ v1.5) 3. Male, aged above 18 years and less than 65 years of age 4. Agree to use a double barrier method of birth control (e.g. condom, diaphragm or cap with spermacide) with a female partner who is, or who could become pregnant, until three months after your last intake of study medication 5. Subject has never received an antiretroviral agent (NRTI, NNRTI, PI, entry inhibitor or integrase inhibitor) for the treatment of HIV and agrees not to start antiretroviral therapy prior to enrollment or subject has only received a short course of treatment for less than 14 days and has been off treatment for at least 8 weeks 6. Subject has no primary mutation in the reverse transcriptase (RT) gene associated with resistance to RT inhibitors and no major mutation in the protease gene associated with resistance to PIs (as defined by IAS-USA Drug Resistance Mutation Group, 2007), determined by genotypic resistance testing at screening or within the past 6 months for a subject who has never received an antiretroviral agent 7. Subject is willing and able to meet the protocol requirements 8. Subject has signed the informed consent form voluntarily Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History or suspicion of alcohol or drug abuse which in the Investigator’s opinion may lead to non-compliance 2. CD4 count 1.5 x ULN 10. Pancreatic amylase or lipase > 1.5 x ULN 11. Hemoglobin 2.5 x ULN 15. Febrile illness within 120-hours prior to dosing 16. Previously received RDEA806 17. History of severe drug allergy or hypersensitivity 18. Significant cardiac dysfunction such as history of cardiac abnormalities including abnormal and clinically relevant ECGs, frequent palpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806 ;Primary end point(s): The primary efficacy parameter is the change from baseline in the log (10) plasma viral load at the end of the treatment period, i.e. the assessment on Day 9. In case of missing data at Day 8, the last available post-baseline non-missing assessment will be used ("endpoint").;Secondary Objective: Efficacy· -to describe the nadir of the plasma viral load -to describe the DAVG -to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log, or reach an undetectable viral load -to assess the plasma viral load decay rate -to evaluate immunologic changes (as measured by CD4 and CD8 cells) -to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics -to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 Safety -to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy | — |
Countries
Austria, Germany, United Kingdom
Outcome results
None listed