HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Saquinavir
Brief summary
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Detailed description
Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.
Interventions
DRUGSaquinavir
DRUGLamivudine
DRUGStavudine
DRUGZidovudine
DRUGZalcitabine
DRUGDidanosine
Sponsors
Hoffmann-La Roche
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * HIV infection. * Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs. * No more than 2 weeks of prior treatment with a protease inhibitor. * No active opportunistic infection or other serious AIDS-defining condition.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Malabsorption or inadequate oral intake. * Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations). * Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry. * Active malignancy or anticipated need for chemotherapy during the study. * Anticipated need for disallowed medications during the study. Concurrent Medication: Excluded: * Other protease inhibitors. Prior Medication: Excluded: * More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen. * More than 2 weeks of any protease inhibitor.
Countries
Canada, United States
Outcome results
None listed