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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002403
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1999
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00002403     History of Changes
Other Study ID Numbers: 290A, UNAP 3, AR177-003
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014