Naïve HIV POC Monotherapy Trial

NCT00617526 | Completed Phase 2

• 1 other identifier: RDEA806-201
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

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

Conditions

HIV Infections

Keywords

HIV; treatment naïve

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HIV plasma viral load

  9 days

Secondary Outcomes (2)

• 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

  22 days

• Pharmacokinetics and Resistance

  22 days

Study Arms (4)

RDEA806 400 mg

EXPERIMENTAL

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

RDEA806 600 mg

EXPERIMENTAL

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

Drug: Placebo; Drug: RDEA806 600 mg

RDEA806 800 mg

EXPERIMENTAL

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

Drug: Placebo; Drug: RDEA806 800 mg

RDEA806 1000 mg

EXPERIMENTAL

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; Drug: RDEA806 1000 mg

Interventions

RDEA806 400 mg DRUG

RDEA806 400 mg

Placebo DRUG

Placebo

RDEA806 1000 mg; RDEA806 400 mg; RDEA806 600 mg; RDEA806 800 mg

RDEA806 1000 mg DRUG

RDEA806 1000 mg

RDEA806 600 mg DRUG

RDEA806 600 mg

RDEA806 800 mg DRUG

RDEA806 800 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (2)

Unknown Facility

Hamburg, 20099, Germany

Location

Unknown Facility

London, SW109NH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20498326 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Vijay Hingorani, MD, PhD

  Ardea Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 28, 2014

Record last verified: 2013-12

Locations

GB (1); DE (1)