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A Trial of PEHRG214 in HIV-Infected Patients

NCT00385567 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-08-26

No results posted yet for this study

Summary

HRG2 is a Phase 2 randomized, controlled, open-label, multi-dose trial to determine the efficacy, safety, immunogenicity, and pharmacokinetic profile of PEHRG214 in HIV-infected patients, treated three times weekly for up to 16 weeks.

All patients are receiving optimized standard of care HAART.

The primary objective of the study is to determine the effect of PEHRG214 in decreasing the viral load (\>=1.0 log10), as compared to a Control group. The primary hypothesis is that treatment with PEHRG214 will result in clinically meaningful and sustained viral load suppression.

The total sample size is 70-74 patients from approximately 8-10 participating study centers. The first 16-20 patients are enrolled in the non-randomized "pilot arm" and 54 subsequent patients are randomized (2:1 within center) to Treatment or Control group. The total study duration is 7-12 months.

Conditions

  • HIV Infections

Interventions

DRUG

PEHRG214

Sponsors & Collaborators

  • Virionyx Corporation Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Puerto Rico

Study Locations

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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 NCT00385567 on ClinicalTrials.gov