the safety and effectiveness of retrovir plus hivid combined with either nevirapine or invirase in the treatment of hiv infection

Conditions: HIV Infections

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.

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.

Eligibility criteria:
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.

Keywords: zalcitabine drug therapy, combination acquired immunodeficiency syndrome aids-related complex zidovudine nevirapine saquinavir