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Naïve HIV POC Monotherapy Trial

NCT00617526 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-01-28

No results posted yet for this study

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

Interventions

DRUG

RDEA806 400 mg

DRUG

Placebo

Placebo

DRUG

RDEA806 1000 mg

DRUG

RDEA806 600 mg

DRUG

RDEA806 800 mg

Sponsors & Collaborators

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Vijay Hingorani, MD, PhD · Ardea Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-06-30
Completion
2008-08-31

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617526 on ClinicalTrials.gov