A Trial of PEHRG214 in HIV-Infected Patients
Public ClinicalTrials.gov record NCT00385567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Controlled Trial of PEHRG214 in HIV-Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00385567
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2006
- Primary completion
- Aug 31, 2008
- Completion
- Aug 31, 2008
- Last update posted
- Aug 25, 2010
2007 – 2008
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| L.A. Gay & Lesbian Center | Los Angeles | California | 90028 | — |
| University of Miami School of Medicine - AIDS Clinical Research Unit | Miami | Florida | 33136 | — |
| Northstar Healthcare | Chicago | Illinois | 60657 | — |
| University of Iowa - HIV/ AIDS Clinical Trials | Iowa City | Iowa | 52242 | — |
| Beth Israel Medical Center - AIDS Clinical Trials Unit | New York | New York | 10003 | — |
| University of Texas Southwestern Medical Center - HIV Research Clinic | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00385567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2010 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00385567 live on ClinicalTrials.gov.