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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

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

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

NCT ID

NCT00617526

First Posted

February 6, 2008

Last Updated

December 20, 2013

Sponsor

Ardea Biosciences, Inc.

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

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

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

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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