Naïve HIV POC Monotherapy Trial

HIV Infections Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617526
• Other study ID #: RDEA806-201
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2008
• Last updated: December 20, 2013
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: December 2013
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• RDEA806 400 mg

• Placebo
Placebo
• RDEA806 1000 mg

• RDEA806 600 mg

• RDEA806 800 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HIV plasma viral load		9 days	No
Secondary	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	Yes
Secondary	Pharmacokinetics and Resistance		22 days	Yes