Naïve HIV POC Monotherapy Trial - Full Text View

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 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: 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: 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 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 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 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 Placebo Drug: RDEA806 1000 mg

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
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

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 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

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

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.


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:	December 20, 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016