Naïve HIV POC Monotherapy Trial - Full Text View

Sponsored by:	Ardea Biosciences, Inc.
Information provided by:	Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00617526

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment
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: 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 ]

Estimated 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
a: Experimental	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).
b: Placebo Comparator	Drug: Placebo Placebo

Arms

Assigned Interventions

a: Experimental

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).

b: Placebo Comparator

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

Responsible Party:	Ardea Biosciences, Inc. ( Kimberly Manhard, Sr. VP Regulatory Affairs and Operations )
Study ID Numbers:	RDEA806-201
Study First Received:	February 6, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00617526 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ardea Biosciences, Inc.:

HIV
treatment naïve

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Antiviral Agents
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 10, 2009