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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
Official Title ^ICMJE	A Phase I/II Multiple Dose Study to Evaluate the Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity of Zintevir (AR177) in HIV-1 Patients
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Zintevir
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002403
Other Study ID Numbers ^ICMJE	290A, UNAP 3, AR177-003
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Aronex Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top