A Multicenter, Open-Label, 24-Week Study to Evaluate the Safety and Activity of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 200 Mg b.i.d. and Two NRTIs in HIV-1 Infected Patients Who Failed PI Therapy
Indinavir sulfate
+ Ritonavir
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Patients receive indinavir and ritonavir twice daily plus 2 NRTIs (NRTIs are not provided by this study). Physical examinations and laboratory tests, including plasma viral RNA levels and CD4 cell counts, are performed at Day 1 and Weeks 4, 8, 12, 16, 20, and 24 (or at discontinuation). The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety. The proportion of patients achieving plasma viral RNA levels below 50 copies/ml (by UltraSensitive assay) are estimated statistically to determine drug efficacy.
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.30 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 18 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 You may be eligible for this study if you: Are HIV-positive. Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry. Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry. Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly). Experienced treatment failure within 24 weeks of study entry. Are 18 years of age or older. Agree to use effective barrier methods of birth control (such as condoms) during the study. Exclusion Criteria You will not be eligible for this study if you: Are allergic to ritonavir or indinavir. Have hepatitis. Have an abnormal chest x-ray or abnormal liver function tests. Have taken 2 protease inhibitors at the same time for 7 or more days. Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry. Have a medical condition that might make it unsafe for you to take the study drugs. Have experienced resistance to NRTIs and no new NRTI therapy is possible. Have taken certain medications. Abuse alcohol or drugs. 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 8 sites
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, United StatesOuvrir LAC / USC Med Ctr / Infectious Diseases dans Google MapsUniv of Miami School of Medicine
Miami, United StatesNorthwestern Univ / Div of Infect Diseases
Chicago, United StatesChase Braxton Health Service
Baltimore, United States