HIV Infections
Conditions
Keywords
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Mutation, HIV-1 Reverse Transcriptase, HIV Protease, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
Brief summary
The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.
Detailed description
In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.
Interventions
DRUGIndinavir sulfate
DRUGRitonavir
DRUGAbacavir sulfate
DRUGAmprenavir
DRUGNelfinavir mesylate
DRUGSaquinavir
Sponsors
Glaxo Wellcome
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Local treatment for Kaposi's sarcoma. * GM-CSF, G-CSF or erythropoietin. Patients must have: * HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture. * CD4+ cell count \>= 100 cells/mm3 within 14 days of study drug administration. * HIV-1 RNA \>= 5,000 copies/ml within 14 days of study drug administration. * No active or ongoing AIDS-defining opportunistic infection or disease. * Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Prior Medication: Allowed: Local treatment for Kaposi's sarcoma.
Exclusion criteria
Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication. * Life-threatening infection or other serious medical condition that may compromise a patient's safety. Concurrent Medication: Excluded: * Other investigational agents. NOTE: * Those available through Treatment IND or expanded access programs are evaluated individually. * Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma). * Agents with documented anti-HIV activity in vitro. * Foscarnet. * Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons. * Antioxidants. Concurrent Treatment: Excluded: Radiation therapy within the first 24 weeks of study. Patients with the following prior conditions are excluded: * History of clinically relevant pancreatitis or hepatitis within the last 6 months. * Participation in an investigational HIV-1 vaccine trial. Prior Medication: Excluded: * Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy. * Cytotoxic chemotherapeutic agents within 30 days of study drug administration. * HIV-1 vaccine dose within the 3 months prior to study drug administration. * Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration. Prior Treatment: Excluded: Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.
Countries
United States
Outcome results
None listed