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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Aronex Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 12

Location and Contact Information:

Cornell AIDS Clinical Trials Unit
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  290A;  UNAP 3,AR177-003
Study Start Date: 
Record last reviewed: December 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002403

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2. The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium avium Complex (MAC) Infection in HIV-Infected Patients

3. A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

4. A Study Comparing 4 Doses Of S-1360 Versus Placebo In HIV-Infected Patients.

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