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

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 are asked to return to the clinic periodically for blood sample collection. Patients may remain at the hospital overnight for pharmacokinetic evaluation. Drug safety, tolerance, efficacy, and pharmacokinetics are measured. Samples from treatment Group 4 are analyzed for specific cell function.

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.