A multicenter Phase 2a, randomized, double-blind, placebo-controlled, proof-of-concept trial to determine the antiviral activity, pharmacokinetics, tolerability and safety of RDEA806 in HIV-1 positive, antiretroviral naïve subjects. - Naïve HIV POC Monotherapy Trial
- Conditions
- HIV-1MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection
- Registration Number
- EUCTR2007-005854-21-DE
- Lead Sponsor
- Ardea Biosciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 36
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method