A Multicenter, Randomized, Double-Blind, Phase 2b Trial to Determine The Efficacy, Tolerability And Safety Of 3 Dose Regimens Of RDEA806 and Open-Label Efavirenz as Active Control in HIV 1-Infected, Antiretroviral Naïve Subjects - Dose Response Naive Efficacy Study

• Conditions: HIV infection; MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2008-005113-21-GB
• Lead Sponsor: Ardea Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

-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 < 50, pancreatic amylase or lipase > 1.5 x ULN, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ? 1.5 x ULN, platelet count < 75 x 109 cells/l (75,000/?l), or absolute neutrophil count < 0.75 x 109 cells/l (1,000 cells/?l)
-Febrile illness within 120 hours prior to initiation of study treatment
-Previously treatment with RDEA806
-History of severe drug allergy or hypersensitivity
-History of cardiac abnormalities including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate < 50 bpm), incomplete left bundle branch block (LBBB), complete LBBB and incomplete right bundle branch block (RBBB) and complete RBBB, second or third degree heart block, intraventricular conduction delay with QRS duration > 120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-exc

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified