A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
Lopinavir/Ritonavir
+ Nevirapine
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Patients receive 1 of the following: ABT-378/RTV plus NVP plus 2 NRTIs; or Investigator-selected PI(s) plus NVP plus 2 NRTIs.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.300 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 12 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Patients may be eligible for this study if they: Are at least 12 years old. Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml. Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks. Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir. Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control. Exclusion Criteria Patients will not be eligible for this study if they: Have an active illness. Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry. Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI). Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry. Have received treatment with a PI other than their current PI. Are receiving chemotherapy for cancer. Are pregnant or breast-feeding.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 88 sites
Univ of Alabama at Birmingham
Birmingham, United StatesOuvrir Univ of Alabama at Birmingham dans Google MapsPhoenix Body Positive
Phoenix, United StatesPacific Oaks Med Group
Beverly Hills, United StatesOrange County Ctr for Special Immunology
Fountain Valley, United States