Back to resultsSafety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zintevir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Dose-Response Relationship, Drug, HIV Integrase Inhibitors, HIV Integrase
Eligibility 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.
Sites / Locations
- Cornell AIDS Clinical Trials Unit
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002403
Brief Title
Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Aronex Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Dose-Response Relationship, Drug, HIV Integrase Inhibitors, HIV Integrase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zintevir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Cornell AIDS Clinical Trials Unit
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
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