Naïve HIV POC Monotherapy Trial

A

Ardea Biosciences

Status and phase

Completed
Phase 2

Conditions

HIV Infections

Treatments

Drug: Placebo
Drug: RDEA806 800 mg
Drug: RDEA806 1000 mg
Drug: RDEA806 400 mg
Drug: RDEA806 600 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617526
RDEA806-201

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No 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

Trial design

48 participants in 4 patient groups

RDEA806 400 mg
Experimental group
Description:
Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8.
Treatment:
Drug: RDEA806 400 mg
Drug: Placebo
RDEA806 600 mg
Experimental group
Description:
Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8.
Treatment:
Drug: RDEA806 600 mg
Drug: Placebo
RDEA806 800 mg
Experimental group
Description:
Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8.
Treatment:
Drug: RDEA806 800 mg
Drug: Placebo
RDEA806 1000 mg
Experimental group
Description:
Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8.
Treatment:
Drug: RDEA806 1000 mg
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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