HIV infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: RDEA806
Product Name: RDEA806
Product Code: RDEA806
Pharmaceutical Form: Film-coated tablet
CAS Number: 878670-63-4
Current Sponsor code: RDEA806
Other descriptive name: RDEA806
Concentrat
Sponsors
Ardea Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Voluntarily signed the informed consent form for this study -Documented chronic HIV-1 infection -HIV-1 plasma viral load at screening visit greater than 5000 HIV-1 RNA copies/ml (assayed by Roche Amplicor HIV-1 Monitor™ v1.5) -CD4 count > 50 cells/mm3 -Male or female at least 16 years of age (or minimum age as determined by local regulatory authorities) -A negative urine pregnancy test at the baseline visit prior to receiving the first dose of study drug, for women of childbearing potential. Women of childbearing potential include all females who have not undergone successful surgical sterilization or are not post-menopausal (ie, no menstrual periods for at least 2 years). -Women of childbearing potential and males must agree to use a non-hormonal double barrier method of birth control (e.g., condom, diaphragm or cap, with a spermicide). -Antiretroviral treatment naïve (see Exclusion Criteria #6) and agrees not to start antiretroviral therapy prior to enrollment or has only received limited exposure of treatment for 14 days or less and has been off treatment for at least 3 months prior to screening -Willing and able to meet the protocol requirements -General medical condition, in the Investigator’s opinion, does not interfere with the assessments and completion of this trial. Are the trial subjects under 18? yes 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: -History or suspicion of alcohol or drug abuse which in the Investigator’s opinion may lead to noncompliance -Life expectancy of less than 6 months -HIV-2 co-infections -Lactating women, or planned pregnancy during the study period -History of any malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer -Prior use of any antiretroviral agent (NRTI, NNRTI, PI, entry inhibitor or integrase inhibitor) for the treatment of HIV -Previous therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent, or initiation of therapy with such agents within 60 days prior to randomization, or the expected need for such therapy during the study period. Note: Trimethoprim-sulfamethoxazole (Bactrim) cannot be initiated 30 days prior to randomization but can be continued if the subject was on stable therapy. -Clinically significant malabsorption syndrome, chronic diarrhea (4 to 10 stools/day for 30 days or greater duration), sprue, Whipple’s disease, pancreatic disease, irritable bowel syndrome, Crohn’s disease, ulcerative colitis, or amyloidosis -Concomitant therapy or required use of astemizole, bepridil, cisapride, midazolam, pimozide, triazolam, voriconazole, St. John's wort (Hypericum perforatum), ergot derivatives, or use of medications prohibited during the study (refer to list of excluded medications, Section 5.9) -Receipt of any investigational drug within 30 days prior to the trial drug (RDEA806) administration or expected need for such therapy during the study period -Treatment within 30 days prior to screening with any vaccine or with any immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin -Acute HIV-1 infection (seroconversion illness), 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), suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or acute hepatitis A or acute or chronic hepatitis B or C infection, with the exception of cutaneous Kaposi’s sarcoma not requiring chemotherapy. -Diagnosis of cirrhosis of the liver. -Treatment for an active opportunistic infection (OI), or unexplained temperature >38.5°C for 7 consecutive days within 30 days prior to randomization -Clinically significant laboratory test abnormalities including: serum creatinine > 1.5 x upper limit of normal (ULN) or Creatinine CL 1.5 x ULN, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ? 1.5 x ULN, platelet count 120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-exc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the antiviral activity at 24 weeks across 3 doses of RDEA806 (non-nucleoside reverse transcriptase inhibitor [NNRTI]) and the efavirenz regimen (proportion of subjects with human immunodeficiency virus ribonucleic acid (HIV RNA) 500 copies/mL) to determine HIV resistance mutations and susceptibility to RDEA806 or efavirenz and to the components of the treatment regimens. | — |
Countries
Germany, United Kingdom
Outcome results
None listed