HIV Infections
Conditions
Keywords
HIV-1, Administration, Oral, CD4 Lymphocyte Count, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir
Brief summary
The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.
Detailed description
Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.
Interventions
DRUGAbacavir sulfate
Sponsors
Glaxo Wellcome
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: Erythropoietin, G-CSF and GM-CSF. Patients must have: * CD4+ cell count \< 100 cells/mm3. * HIV-1 RNA \> 30,000 copies/ml. * Signed, informed consent from parent or legal guardian for patient under 18 years of age.
Exclusion criteria
Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Renal failure requiring dialysis. * Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal. * Documented hypersensitivity to 1592U89. * Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient. * Participation in or ability to participate in an enrolling study of 1592U89. Required: At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor). Alcohol or illicit drug use that may interfere with the patient's compliance.
Countries
United States
Outcome results
None listed