A Pilot Study of Once-Daily Therapy With Amprenavir, Ritonavir, Lamivudine and Abacavir in HIV-Infected, Antiretroviral-Naive Patients

Fecha de inicio: 1 de enero de 2000

Adults (greater than 18 years) infected with HIV-1. Plasma viral burden greater than 8,000 and less than 60,000 RNA copies per ml. by bDNA method at screening. CD4 cell count above 200 cells per microliter at screen. No prior treatment with any anti-retroviral agent. Laboratory values at screen: hemoglobin greater than 9 g per dl; granulocyte count greater than 900 cells per microliter; platelet count greater than 80,000 cells per microliter; AST (SGOT) less than 151 U/L; creatinine less than 2 mg/dL. Must not be pregnant or breast-feeding and willing to avoid pregnancy by the use of non-hormonal methods of birth control during study participation. Pregnancy test (blood or urine) must be negative within two weeks prior to dosing with study medications. Willing and able to provide written informed consent. No history suggestive of malabsorption. No chronic diarrhea. Must not have had treatment with systemic corticosteroids at greater than physiologic replacement doses, interleukins, interferons, radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or an anticipated need for radiation or chemotherapy treatment within the next 48 weeks (with the exception of local treatment of Kaposi's sarcoma). Must not have current or anticipated therapy with other agents with documented activity against HIV-1 in vitro. Must not have active, untreated opportunistic infection or other major illness that would, in the opinion of the investigator, increase the risk that adverse events might pose to the patient or might render the patient too ill to return for study visits. Must not have significant substance abuse or psychiatric illness that might interfere with assessment or compliance. Must not have current or anticipated future need for any of the following drugs which are contraindicated with an amprenavir-ritonavir regimen because of drug-drug interactions: Terfenadine (Seldane), Astemizole (Hismanal), Cisapride (Propulsid), Triazolam (Halcion), Bepridil (Vascor), Medazolam (Versed), Rifampin (Rifadin, Rifamate, Rifater), Ergotamine/Dihydroergotamine containing regimens (Ergomar, Wygraine, Ercaf, DHE, Migranal), Amiodarone (Cordarone), Flecanaide (Tambocor), Propafenone (Rythmol), Quinidine (Quinaglute, Cardioquin), and Pimozide (Orap). Must not have current or anticipated future need for the following anticonvulsants: phenobarbital, phenytoin, carbamazepine.