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

Launched by HARBOR THERAPEUTICS · Aug 30, 2001

Keywords

ClinConnect Summary

HE2000 is a synthetic steroid hormone that, when tested in the laboratory, had anti-viral activity against wild-type and drug-resistant variants of HIV. HE2000 works through a natural biochemical mechanism in cells to make them less able to support viral infection.

There are 4 treatment groups of increasing doses of HE2000; each group consists of 2 parts (Part A and B). Part A is a single administration of HE2000 injected intramuscularly, and Part B is 5 consecutive daily intramuscular injections of HE2000. Patients receive the same dosage throughout Parts A and B of the study. Patients ar...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.