HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Patient Compliance, Anti-HIV Agents, abacavir
Brief summary
The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.
Detailed description
In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.
Interventions
DRUGLamivudine/Zidovudine
DRUGAbacavir sulfate
DRUGAmprenavir
Sponsors
Glaxo Wellcome
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * CD4 count greater than 50 cells/mm3. * HIV RNA less than 50,000 copies/ml. * No active AIDS (excluding CD4 count less than 200 cells/mm3). * Ability to comply with dosing schedule and protocol evaluations. Prior Medication: Allowed: AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Exclusion criteria
Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: * Active AIDS (not excluding CD4 count less than 200). * Malabsorption syndrome affecting drug absorption. * Serious medical condition that would compromise safety of the patient. Concurrent Medication: Excluded: * AZT or NNRTIs. * More than 1 week treatment with any protease inhibitor. * Enrollment in any other investigational drug protocol. Patients with the following prior conditions are excluded: History of clinically relevant pancreatitis or hepatitis within the past 6 months. Required: Antiretroviral therapy with either single or double reverse transcriptase inhibitors.
Countries
United States
Outcome results
None listed