HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Brief summary
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
Detailed description
This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.
Interventions
DRUGAmprenavir
DRUGLamivudine
DRUGZidovudine
Sponsors
Glaxo Wellcome
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * HIV-positive status. * Screening viral load \>= 10,000 copies/mm3 14 days prior to entry. * CD4+ cell counts \>= 200 cells/mm3 14 days prior to entry.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinical diagnosis of AIDS (CDC 1993 Classification C). Concurrent Medication: Excluded: Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens. Patients with the following prior conditions are excluded: Clinically relevant hepatitis in the previous 6 months. Prior Medication: Excluded: * Greater than 4 weeks of any nucleoside antiretroviral therapy. * Previous therapy with an HIV protease inhibitor. * Cytotoxic chemotherapeutic agents within 4 weeks prior to entry. * Immunomodulating agents within 3 months prior to entry. Prior Treatment: Excluded: Radiotherapy within 4 weeks prior to entry. Risk Behavior: Excluded: Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.
Countries
United States
Outcome results
None listed