E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 < 350 cells/mm3 (Germany and Austria) or < 200 cells/mm3 (UK) 3. Life expectancy of less than 6 months 4. Receipt of an investigational drug within 30 days prior to the trial drug administration 5. Receipt of any vaccine within 30 days of screening visit 6. Acute HIV-1 infection (seroconversion illness) 7. Acute hepatitis A or acute or chronic hepatitis B or C infection 8. Currently active acquired immune deficiency syndrome (AIDS)-defining illness (Category C conditions according to the Centers for Disease Control [CDC] Classification System for HIV Infection 1993, Appendix B) 9. Renal impairment: serum creatinine > 1.5 x ULN 10. Pancreatic amylase or lipase > 1.5 x ULN 11. Hemoglobin < 5.10 mmol/l (9.1 g/dl) for men 12. Platelet count < 75 x 109 cells/l (75,000/μl) 13. Absolute neutrophil count < 1.0 x 109 cells/l (1,000 cells/μl) 14. ALT, AST, or GGT > 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. |
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E.5 End points |
E.5.1 | 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"). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |