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Naïve HIV POC Monotherapy Trial

This study has been completed.
Information provided by (Responsible Party):
Ardea Biosciences, Inc. Identifier:
First received: February 6, 2008
Last updated: December 20, 2013
Last verified: December 2013

The primary objective of the trial is:

• to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806.

The secondary objectives are:


  • 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

Condition Intervention Phase
HIV Infections Drug: RDEA806 400 mg Drug: Placebo Drug: RDEA806 1000 mg Drug: RDEA806 600 mg Drug: RDEA806 800 mg Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Ardea Biosciences, Inc.:

Primary Outcome Measures:
  • Change from baseline in HIV plasma viral load [ Time Frame: 9 days ]

Secondary Outcome Measures:
  • Safety will be assessed as adverse and HIV related events, clinical laboratory test results(hematology, chemistry, urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination [ Time Frame: 22 days ]
  • Pharmacokinetics and Resistance [ Time Frame: 22 days ]

Enrollment: 48
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RDEA806 400 mg
Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8.
Drug: RDEA806 400 mg Drug: Placebo
Experimental: RDEA806 600 mg
Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8.
Drug: Placebo
Drug: RDEA806 600 mg
Experimental: RDEA806 800 mg
Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8.
Drug: Placebo
Drug: RDEA806 800 mg
Experimental: RDEA806 1000 mg
Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8.
Drug: Placebo
Drug: RDEA806 1000 mg


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented chronic HIV-1 infection
  • HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/ml
  • Male, aged above 18 years and less than 65 years of age
  • Adequate method of birth control
  • 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
  • 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 determined by genotypic resistance testing at screening

Exclusion Criteria:

  • History or suspicion of alcohol or drug abuse which in the Investigator's opinion may lead to non-compliance
  • CD4 count < 350 cells/mm3
  • Life expectancy of less than 6 months
  • Receipt of an investigational drug within 30 days prior to the trial drug administration
  • Receipt of any vaccine within 30 days of screening visit
  • Acute HIV-1 infection (seroconversion illness)
  • Acute hepatitis A or acute or chronic hepatitis B or C infection
  • 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)
  • No clinically relevant laboratory abnormalities Renal impairment: serum creatinine > 1.5 x ULN
  • Febrile illness within 120 hours prior to dosing
  • History of severe drug allergy or hypersensitivity
  • Significant cardiac dysfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00617526

Hamburg, Germany, 20099
United Kingdom
London, United Kingdom, SW109NH
Sponsors and Collaborators
Ardea Biosciences, Inc.
Study Director: Vijay Hingorani, MD, PhD Ardea Biosciences
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ardea Biosciences, Inc. Identifier: NCT00617526     History of Changes
Other Study ID Numbers: RDEA806-201
Study First Received: February 6, 2008
Last Updated: December 20, 2013

Keywords provided by Ardea Biosciences, Inc.:
treatment naïve

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on September 21, 2017