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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Aronex Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002403

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Zintevir	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study
Official Title:	A Phase I/II Multiple Dose Study to Evaluate the Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity of Zintevir (AR177) in HIV-1 Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002403

Locations

United States, New York
Cornell AIDS Clinical Trials Unit
New York, New York, United States, 10021

Sponsors and Collaborators

Aronex Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	290A, UNAP 3, AR177-003
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002403 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Dose-Response Relationship, Drug
HIV Integrase Inhibitors
HIV Integrase

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
HIV Integrase Inhibitors

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Retroviral Agents
Integrase Inhibitors
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009