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

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

MedlinePlus related topics:

AIDS

U.S. FDA Resources

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

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

Estimated Enrollment:

12

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

Study ID Numbers:	290A, UNAP 3, AR177-003
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002403
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on December 03, 2008

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