a study of 1592u89 in combination with protease inhibitors in hiv-infected patients who have never taken anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give 1592u89 plus certain protease inhibitors (pis) to hiv-infected patients who never have been treated with anti-hiv drugs. this study also examines how the body processes these drugs when they are given together.

in this phase ii, open-label study patients (16 per treatment group) are randomized to receive 1592u89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141w94 for up to 48 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * local treatment for kaposi's sarcoma. * gm-csf, g-csf or erythropoietin. patients must have: * hiv-1 infection documented by a licensed hiv-1 antibody elisa and confirmed by western blot detection of hiv-1 antibody or a positive hiv-1 blood culture. * cd4+ cell count \>= 100 cells/mm3 within 14 days of study drug administration. * hiv-1 rna \>= 5,000 copies/ml within 14 days of study drug administration. * no active or ongoing aids-defining opportunistic infection or disease. * signed, informed consent from parent or legal guardian for patients less than 18 years of age. prior medication: allowed: local treatment for kaposi's sarcoma. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication. * life-threatening infection or other serious medical condition that may compromise a patient's safety. concurrent medication: excluded: * other investigational agents. note: * those available through treatment ind or expanded access programs are evaluated individually. * chemotherapeutic agents for the initial 24 weeks of study (except local treatment for kaposi's sarcoma). * agents with documented anti-hiv activity in vitro. * foscarnet. * immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons. * antioxidants. concurrent treatment: excluded: radiation therapy within the first 24 weeks of study. patients with the following prior conditions are excluded: * history of clinically relevant pancreatitis or hepatitis within the last 6 months. * participation in an investigational hiv-1 vaccine trial. prior medication: excluded: * antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy. * cytotoxic chemotherapeutic agents within 30 days of study drug administration. * hiv-1 vaccine dose within the 3 months prior to study drug administration. * immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration. prior treatment: excluded: radiation therapy within 30 days of study drug administration. alcohol or illicit drug use that may interfere with patient compliance.

Keywords: hiv-1 drug therapy, combination hiv protease inhibitors mutation hiv-1 reverse transcriptase hiv protease reverse transcriptase inhibitors anti-hiv agents abacavir