HIV Infections
Conditions
Keywords
HIV-1, Dose-Response Relationship, Drug, HIV Integrase Inhibitors, HIV Integrase
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.
Interventions
DRUGZintevir
Sponsors
Aronex Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed