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

Aronex Pharmaceuticals12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

ZintevirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cornell AIDS Clinical Trials Unit

New York, New York, United States

Data from ClinicalTrials.gov

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