HIV Infections
Conditions
Keywords
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Nevirapine, Saquinavir
Brief summary
To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection. Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ). Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.
Detailed description
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available. Patients are randomized to receive AZT/ddC either alone or in combination with nevirapine or Ro 31-8959 for a minimum of 48 weeks. Patients are followed at weeks 2 and 4 and every 4 weeks thereafter.
Interventions
DRUGSaquinavir
DRUGNevirapine
DRUGZidovudine
DRUGZalcitabine
Sponsors
Parexel
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Encouraged: * PCP chemoprophylaxis for patients whose CD4 count falls below 200 cells/mm3 or who develop PCP on study. Allowed: * Secondary prophylaxis with nonexperimental agents in patients who develop TB, Mycobacterium avium-intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection. * Acyclovir for 21 days or less for acute treatment. * Recombinant erythropoietin and G-CSF for grade 3 or worse anemia and neutropenia, respectively. Patients must have: * HIV infection. * CD4 count 200 - 500 cells/mm3. * No prior antiretroviral therapy. * Life expectancy of at least 48 weeks. * Consent of parent or guardian if less than 18 years of age. NOTE: * Participating centers are encouraged to enroll female patients.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Any grade 3 or greater toxicity. * Symptoms of peripheral neuropathy. * Malabsorption or severe chronic diarrhea. * Inability to eat at least one meal daily because of chronic nausea, emesis, or abdominal or esophageal discomfort. Concurrent Medication: Excluded during the first 28 days of nevirapine administration: * Augmentin and other antibiotics containing clavulanic acid. Excluded at any time: * Dicumarol, warfarin, and other anticoagulant medications. * Tolbutamide. * Cimetidine. * Erythromycin. Patients with the following prior conditions are excluded: * History of acute or chronic pancreatitis. * History of grade 2 or worse peripheral neuropathy from any cause. Prior Medication: Excluded: * Any prior antiretroviral therapy. Excluded within 4 weeks prior to study entry: * Immunomodulating agents such as systemic corticosteroids, IL-2, alpha-interferon, beta-interferon, or gamma-interferon. * Immunotherapeutic vaccines. * Cytotoxic chemotherapy. * Erythromycin. * Dicumarol, Coumadin / warfarin, and other anticoagulant medications. * Phenobarbital. * Amoxicillin / clavulanate. * Ticarcillin / clavulanate. * Tolbutamide. * Erythromycin. * Cimetidine. Prior Treatment: Excluded within 4 weeks prior to study entry: * Non-local radiation therapy. Current alcohol or illicit drug use that would interfere with ability to comply with study requirements.
Countries
United States
Outcome results
None listed