A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy
A Phase I/II, Open-Label Study of the Safety, Tolerance, Pharmacokinetics, Drug-Interaction and Anti-HIV Activity of Intramuscularly Administered Alpha-Epi-Br (HE2000) in HIV-Infected Patients on Salvage Therapy
2 other identifiers
interventional
42
1 country
6
Brief Summary
The purpose of this study is to see if it is safe and effective to give HE2000, an experimental anti-HIV drug, to HIV-infected patients on salvage therapy (emergency treatment used when a patient has not responded to standard therapy). HE2000 is a hormone that is suspected to make it more difficult for HIV to live in cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 25, 2009
April 1, 2002
November 2, 1999
June 24, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Have been on their current anti-HIV drug combination for at least 30 days prior to the screening visit.
- Are currently failing at least their second anti-HIV drug treatment.
- Are not responding to their current anti-HIV treatment, have failed at least 1 anti-HIV combination, and do not have many options for treatment (Groups 3 and 4 only).
- Are willing to not make any changes in their anti-HIV treatment until at least Day 50 during the study.
- Have a CD4 count of at least 100 cells/mm3 at study entry.
- Have a viral load (level of HIV in the body) between 5,000 and 250,000 copies/ml at study entry.
- Agree to use barrier methods of birth control (e.g., condoms) during the study.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have hepatitis B or C.
- Have been treated for cancer within 4 weeks prior to study entry, or will need to be treated during the study. (Patients with Kaposi's sarcoma are eligible but must not have received any treatment within 4 weeks before study entry or require treatment during the study.)
- Have received certain medications including those affecting the immune system.
- Are pregnant or breast-feeding.
- Have an active, serious infection, including opportunistic (AIDS-defining) infection that requires treatment during the study or during the 2 weeks prior to study entry.
- Have a condition or are receiving therapy that would prevent them from completing the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
ViRx Inc
Palm Springs, California, 92262, United States
Veterans Affairs Palo Alto Health Care Ctr
Palo Alto, California, 94304, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
St Vincents Hosp / Clinical Research Program
New York, New York, 10011, United States
Plaza Med Ctr
Houston, Texas, 77004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 25, 2009
Record last verified: 2002-04