HIV InfectionsPhase 2NCT00385567
A Trial of PEHRG214 in HIV-Infected Patients
A Phase 2 study testing PEHRG214 in people with HIV Infections, run by Virionyx Corporation Limited at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- PEHRG214
- How many people
- 70 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serological documentation of HIV infection at any time prior to study entry.
- CD4 cells count of <220 cells/mm3 within 35 days of study drug administration.
- Viral load at least 10 times greater than the site laboratory's lower limit of detection within 35 days of study drug administration.
- The patient must be taking an optimized background regimen (OBR) of antiretroviral agents, as confirmed by the Principal Investigator, in accordance with the US Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, May 4, 2006; (http://www.aidsinfo.nih.gov/guidelines/) or comparable standard of care guidelines.
- OBR has been individually selected for the patient based on prior viral resistance testing and antiretroviral treatment history.
- OBR has been stable for at least 4 weeks prior to Screening and is expected to remain stable for the duration of the trial.
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- Karnofsky performance status >=60%.
- Adequate laboratory parameters: absolute neutrophil count >1000 cells/mm3 hemoglobin >9.0 g/dL; platelets >75,000/mm3; creatinine <1.5 x upper limit of normal; SGOT/SGPT <3.0 x upper limit of normal; bilirubin <2.0 mg/dL. Note: Patients who are taking indinavir or atazanavir will be allowed on this trial if their bilirubin is >3.0 mg/dL and if it is deemed by both the Principal Investigator and patient's physician that the elevated bilirubin is solely related to indinavir or atazanavir.
- Women of Child Bearing Potential (WOCBP) must have a negative serum or urine pregnancy test.
- Prophylaxis for Pneumocystis carinii pneumonia using aerosolized pentamidine, trimethoprim/sulfamethoxazole, mepron or dapsone is required for study patients.
- Signed informed consent.
Who cannot join
- Patient is pregnant or lactating.
- Active opportunistic infection which is progressive, or imminently disabling or life-threatening, in the judgment of the Principal Investigator.
- Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks (patients who have received intralesional chemotherapy will not be excluded, however).
- Any investigational drugs within 30 days or any investigational biologic agents within 6 weeks. Patients taking antiretroviral investigational drugs within Expanded Access Programs (21CFR312.34) are not excluded from participation, provided these drugs are not excluded elsewhere in the protocol.
- Patients who have received an HIV vaccine.
- Known hypersensitivity to animal proteins, including red meats, milk, or milk products, or previous treatment with a caprine antibody and HAGAR (Human anti-goat antibody response) or the presence of HAGAR at screening.
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- As this is an experimental regimen, patients will not be permitted to enroll if they had been on an effective antiretroviral regimen, which they tolerated well and which they discontinued for the sake of enrolling in this protocol.
- Active drug abuse.
- Any condition which in the Principal Investigator's opinion may render the patient unable to complete the study or which may pose significant risk to the patient.
- Chronic treatment with immunosuppressant drugs, including corticosteroids, except for the treatment of adrenal insufficiency. Topical steroids are permitted.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Northstar Healthcare
Chicago, Illinois, 60657
University of Texas Southwestern Medical Center - HIV Research Clinic
Dallas, Texas, 75390
University of Iowa - HIV/ AIDS Clinical Trials
Iowa City, Iowa, 52242
L.A. Gay & Lesbian Center
Los Angeles, California, 90028
University of Miami School of Medicine - AIDS Clinical Research Unit
Miami, Florida, 33136
Beth Israel Medical Center - AIDS Clinical Trials Unit
New York, New York, 10003
About this study
Official title: A Phase 2 Randomized, Controlled Trial of PEHRG214 in HIV-Infected Patients
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.
Read more
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.
Read the detailed description
The study design is a randomized, controlled, open-label multi-dose trial of PEHRG214 administered intravenously three times weekly, with the potential for dose escalation in selected patients. Patients with HIV infection, viral load at least 10 times greater than the site laboratory's lower limit of detection and CD4 count of <220 cells/mm3, will be entered into the trial. All patients must be taking an optimized background regimen (OBR) of antiretroviral agents, as confirmed by the Principal Investigator, in accordance with the U.S. Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, May 4, 2006.
A non-randomized "pilot arm" of 16-20 patients will first receive 2.0 mg/kg three times weekly for 12 doses. After a "pilot arm" patient has received at least 12 doses of PEHRG214 at 2.0 mg/kg, dose escalation to 4.0 mg/kg three times weekly will follow a scheme based on adverse event, HAGAR, and viral load assessments for each individual patient, and in certain cases, further review by the DSMB. After the "pilot arm" patients have received 12 doses at 4.0 mg/kg, all subsequent patients will enter the protocol at the 4.0 mg PEHRG214/kg level. The subsequent 54 patients will be randomized, in 2:1 ratio within center, to the Treatment group and Control group, respectively. The treatment group will receive PEHRG214 at a dose of 4.0 mg/kg three times weekly for up to 48 doses (16 weeks). The Control group will not receive the investigational drug, but will undergo observation while receiving standard of care HAART.
After at least 12 doses of PEHRG214 at 4.0 mg/kg, dose escalation to 8.0 mg/kg three times weekly will follow a scheme based on adverse event, HAGAR, and viral load assessments for each individual patient, and in certain cases, further review by the DSMB.
The Control patients will be evaluated every 4 weeks for 16 weeks according to the Schedule of Assessments in Appendix 1F. After 16 weeks, these patients will have the option of being enrolled in an extension protocol where they can receive PEHRG214.
- Conditions
- HIV Infections
- Being tested
- PEHRG214
- Keywords
- AIDS, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEHRG214Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in viral load >= 1.0 log10 at 16 weeks
Positive changes in CD4 count, weight, and Karnofsky Performance Score at 16 weeks
Improvement in quality of life as determined monthly, using the MOS-HIV Health Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Difficulty recruiting eligible patients in timely fashion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virionyx Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385567
- Sponsor's protocol ID
- HRG2
- Status last verified
- Aug 2010
- First submitted
- 1 Oct 2006
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verity EE, Williams LA, Haddad DN, Choy V, O'Loughlin C, Chatfield C, Saksena NK, Cunningham A, Gelder F, McPhee DA. Broad neutralization and complement-mediated lysis of HIV-1 by PEHRG214, a novel caprine anti-HIV-1 polyclonal antibody. AIDS. 2006 Feb 28;20(4):505-15. doi: 10.1097/01.aids.0000210604.78385.95.
PubMed 16470114Dezube BJ, Proper J, Zhang J, Choy VJ, Weeden W, Morrissey J, Burns EM, Dixon JD, O'Loughlin C, Williams LA, Pickering PJ, Crumpacker CS, Gelder FB. A passive immunotherapy, (PE)HRG214, in patients infected with human immunodeficiency virus: a phase I study. J Infect Dis. 2003 Feb 1;187(3):500-3. doi: 10.1086/367710. Epub 2003 Jan 8.
PubMed 12552435Pett SL, Williams LA, Day RO, Lloyd AR, Carr AD, Clezy KR, Emery S, Kaplan E, McPhee DA, McLachlan AJ, Gelder FB, Lewin SR, Liauw W, Williams KM. A phase I study of the pharmacokinetics and safety of passive immunotherapy with caprine anti-HIV antibodies, (PE)HRG214, in HIV-1-infected individuals. HIV Clin Trials. 2004 Mar-Apr;5(2):91-8. doi: 10.1310/1FLN-8KFC-5HEQ-K19J.
PubMed 15116285
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Controlled Trial of PEHRG214 in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00385567
- Acronym / sponsor ID
- HRG2
- Conditions
- HIV Infections
- Keywords
- AIDS, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting eligible patients in timely fashion
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Virionyx Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study design is a randomized, controlled, open-label multi-dose trial of PEHRG214 administered intravenously three times weekly, with the potential for dose escalation in selected patients. Patients with HIV infection, viral load at least 10 times greater than the site laboratory's lower limit of detection and CD4 count of <220 cells/mm3, will be entered into the trial. All patients must be taking an optimized background regimen (OBR) of antiretroviral agents, as confirmed by the Principal Investigator, in accordance with the U.S. Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, May 4, 2006.
A non-randomized "pilot arm" of 16-20 patients will first receive 2.0 mg/kg three times weekly for 12 doses. After a "pilot arm" patient has received at least 12 doses of PEHRG214 at 2.0 mg/kg, dose escalation to 4.0 mg/kg three times weekly will follow a scheme based on adverse event, HAGAR, and viral load assessments for each individual patient, and in certain cases, further review by the DSMB. After the "pilot arm" patients have received 12 doses at 4.0 mg/kg, all subsequent patients will enter the protocol at the 4.0 mg PEHRG214/kg level. The subsequent 54 patients will be randomized, in 2:1 ratio within center, to the Treatment group and Control group, respectively. The treatment group will receive PEHRG214 at a dose of 4.0 mg/kg three times weekly for up to 48 doses (16 weeks). The Control group will not receive the investigational drug, but will undergo observation while receiving standard of care HAART.
After at least 12 doses of PEHRG214 at 4.0 mg/kg, dose escalation to 8.0 mg/kg three times weekly will follow a scheme based on adverse event, HAGAR, and viral load assessments for each individual patient, and in certain cases, further review by the DSMB.
The Control patients will be evaluated every 4 weeks for 16 weeks according to the Schedule of Assessments in Appendix 1F. After 16 weeks, these patients will have the option of being enrolled in an extension protocol where they can receive PEHRG214.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Serological documentation of HIV infection at any time prior to study entry.
- CD4 cells count of <220 cells/mm3 within 35 days of study drug administration.
- Viral load at least 10 times greater than the site laboratory's lower limit of detection within 35 days of study drug administration.
- The patient must be taking an optimized background regimen (OBR) of antiretroviral agents, as confirmed by the Principal Investigator, in accordance with the US Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, May 4, 2006; (http://www.aidsinfo.nih.gov/guidelines/) or comparable standard of care guidelines.
- OBR has been individually selected for the patient based on prior viral resistance testing and antiretroviral treatment history.
Key exclusion criteria (10 listed)
- Patient is pregnant or lactating.
- Active opportunistic infection which is progressive, or imminently disabling or life-threatening, in the judgment of the Principal Investigator.
- Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks (patients who have received intralesional chemotherapy will not be excluded, however).
- Any investigational drugs within 30 days or any investigational biologic agents within 6 weeks. Patients taking antiretroviral investigational drugs within Expanded Access Programs (21CFR312.34) are not excluded from participation, provided these drugs are not excluded elsewhere in the protocol.
- Patients who have received an HIV vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEHRG214 | Drug | – |
Primary outcome
Decrease in viral load >= 1.0 log10 at 16 weeks
Positive changes in CD4 count, weight, and Karnofsky Performance Score at 16 weeks
Improvement in quality of life as determined monthly, using the MOS-HIV Health Survey
Results and safety
The study was stopped early (reason given: Difficulty recruiting eligible patients in timely fashion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
- Background: PubMed 16470114Verity EE, Williams LA, Haddad DN, Choy V, O'Loughlin C, Chatfield C, Saksena NK, Cunningham A, Gelder F, McPhee DA. Broad neutralization and complement-mediated lysis of HIV-1 by PEHRG214, a novel caprine anti-HIV-1 polyclonal antibody. AIDS. 2006 Feb 28;20(4):505-15. doi: 10.1097/01.aids.0000210604.78385.95.
- Background: PubMed 12552435Dezube BJ, Proper J, Zhang J, Choy VJ, Weeden W, Morrissey J, Burns EM, Dixon JD, O'Loughlin C, Williams LA, Pickering PJ, Crumpacker CS, Gelder FB. A passive immunotherapy, (PE)HRG214, in patients infected with human immunodeficiency virus: a phase I study. J Infect Dis. 2003 Feb 1;187(3):500-3. doi: 10.1086/367710. Epub 2003 Jan 8.
- Background: PubMed 15116285Pett SL, Williams LA, Day RO, Lloyd AR, Carr AD, Clezy KR, Emery S, Kaplan E, McPhee DA, McLachlan AJ, Gelder FB, Lewin SR, Liauw W, Williams KM. A phase I study of the pharmacokinetics and safety of passive immunotherapy with caprine anti-HIV antibodies, (PE)HRG214, in HIV-1-infected individuals. HIV Clin Trials. 2004 Mar-Apr;5(2):91-8. doi: 10.1310/1FLN-8KFC-5HEQ-K19J.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEHRG214 in people with HIV Infections, run by Virionyx Corporation Limited at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting eligible patients in timely fashion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in viral load >= 1.0 log10 at 16 weeks. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385567, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2010.