Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
|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.|
|ClinicalTrials.gov Identifier: NCT00002403|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Zintevir||Phase 1|
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 :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Masking:||None (Open Label)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002403
|United States, New York|
|Cornell AIDS Clinical Trials Unit|
|New York, New York, United States, 10021|