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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002403
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
A Phase I/II Multiple Dose Study to Evaluate the Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity of Zintevir (AR177) in HIV-1 Patients

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.

Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Zintevir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002403
290A
UNAP 3
AR177-003
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Aronex Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
December 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP