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Naïve HIV POC Monotherapy Trial

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RDEA806 400 mg
Placebo
RDEA806 1000 mg
RDEA806 600 mg
RDEA806 800 mg
Sponsored by
Ardea Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, treatment naïve

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

RDEA806 400 mg

RDEA806 600 mg

RDEA806 800 mg

RDEA806 1000 mg

Arm Description

Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8.

Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8.

Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8.

Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8.

Outcomes

Primary Outcome Measures

Change from baseline in HIV plasma viral load

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
Pharmacokinetics and Resistance

Full Information

First Posted
February 6, 2008
Last Updated
December 20, 2013
Sponsor
Ardea Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00617526
Brief Title
Naïve HIV POC Monotherapy Trial
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardea Biosciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, treatment naïve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RDEA806 400 mg
Arm Type
Experimental
Arm Description
Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8.
Arm Title
RDEA806 600 mg
Arm Type
Experimental
Arm Description
Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8.
Arm Title
RDEA806 800 mg
Arm Type
Experimental
Arm Description
Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8.
Arm Title
RDEA806 1000 mg
Arm Type
Experimental
Arm Description
Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8.
Intervention Type
Drug
Intervention Name(s)
RDEA806 400 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
RDEA806 1000 mg
Intervention Type
Drug
Intervention Name(s)
RDEA806 600 mg
Intervention Type
Drug
Intervention Name(s)
RDEA806 800 mg
Primary Outcome Measure Information:
Title
Change from baseline in HIV plasma viral load
Time Frame
9 days
Secondary Outcome Measure Information:
Title
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
Title
Pharmacokinetics and Resistance
Time Frame
22 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay Hingorani, MD, PhD
Organizational Affiliation
Ardea Biosciences
Official's Role
Study Director
Facility Information:
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
City
London
ZIP/Postal Code
SW109NH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20498326
Citation
Moyle G, Boffito M, Stoehr A, Rieger A, Shen Z, Manhard K, Sheedy B, Hingorani V, Raney A, Nguyen M, Nguyen T, Ong V, Yeh LT, Quart B. Phase 2a randomized controlled trial of short-term activity, safety, and pharmacokinetics of a novel nonnucleoside reverse transcriptase inhibitor, RDEA806, in HIV-1-positive, antiretroviral-naive subjects. Antimicrob Agents Chemother. 2010 Aug;54(8):3170-8. doi: 10.1128/AAC.00268-10. Epub 2010 May 24.
Results Reference
derived

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Naïve HIV POC Monotherapy Trial

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