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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harbor Therapeutics

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.