Status:
COMPLETED
Naïve HIV POC Monotherapy Trial
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
HIV Infections
Eligibility:
MALE
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00617526
Start Date
January 1 2008
End Date
August 1 2008
Last Update
January 28 2014
Active Locations (2)
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1
Hamburg, Germany, 20099
2
London, United Kingdom, SW109NH