Naïve HIV POC Monotherapy Trial

Ardea Biosciences

Status and phase: Completed; Phase 2

Conditions: HIV Infections

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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: Placebo

Drug: RDEA806 400 mg

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: Placebo

Drug: RDEA806 600 mg

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: Placebo

Drug: RDEA806 800 mg

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: Placebo

Drug: RDEA806 1000 mg