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