A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002422

Run by

Harbor Therapeutics

People needed

42

Last updated by the study team

2009-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• ViRx Inc — Palm Springs, California, United States
• Veterans Affairs Palo Alto Health Care Ctr — Palo Alto, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• St Vincents Hosp / Clinical Research Program — New York, New York, United States
• Plaza Med Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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