A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.
Abacavir sulfate
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location