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Naïve HIV POC Monotherapy Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00617526
First received: February 6, 2008
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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:

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

Condition Intervention Phase
HIV Infections
 Drug: RDEA806
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from baseline in HIV plasma viral load [ Time Frame: 9 days ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics and Resistance [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]

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: a Drug: RDEA806
Subjects in Cohort 1 will receive a bid dose of RDEA806 400 mg for 7 consecutive days followed by a single dose on Day 8. In Cohort 2, subjects will receive a qd dose of RDEA806 600 mg for 7 consecutive days, with an additional dose on Day 8. All subjects will be followed for 2 weeks after the last dose. Cohorts 3 and 4: Study medication will be supplied as RDEA806 Enteric Coated Tablets, 200 mg. Each tablet is a white, film-coated, oval-shaped tablet that weighs approximately 299 mg and contains 200 mg RDEA806. Cohorts 3 and 4 will be dosed with 800 mg qd and 1,000 mg qd (or 400 mg bid), respectively. Subjects in Cohorts 3 and 4 will take the RDEA806 Over-Encapsulated Capsule with 240 mL (approximately 8 ounces) of ambient-temperature water. Subjects will be dosed approximately 30 minutes following breakfast (or approximately 30 minutes following breakfast and dinner in the 400 mg bid dose).
Placebo Comparator: b Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617526

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

No publications provided by Ardea Biosciences, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00617526     History of Changes
Other Study ID Numbers: RDEA806-201
Study First Received: February 6, 2008
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ardea Biosciences, Inc.:
HIV
treatment naïve

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013