Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients

Aronex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Zintevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002403

290A

UNAP 3

AR177-003

Details and patient eligibility

About

The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to asymptomatic (no symptoms) HIV-infected patients.

Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the protein integrase to infect a cell. Integrase inhibitors block integrase and may stop replication of HIV.

Full description

Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. The HIV-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell. Integrase inhibitors block integrase and may stop replication of the HIV-1 virus.

In this open-label, Phase I/II study, 3 groups of HIV-positive patients (12 patients total) receive escalating doses of intravenous zintevir for 14 consecutive days.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive, but do not have any symptoms of HIV infection.
• Have a CD4 count greater than 200 cells/mm3.
• Have a viral load (level of HIV in the body) greater than 4,000 copies/ml.
• Are at least 18 years old.

Exclusion Criteria

You will not be eligible for this study if you:

• Tend to have abnormal bleeding or other blood problems.
• Have an active AIDS-defining illness.
• Have a history of serious disease or illness.
• Abuse alcohol or drugs.
• Have received certain medications.