The Antiviral Effect of Switching From Hard Capsule Saquinavir (SQVhc) to the Soft Gelatin Capsule of Saquinavir (SQVsc) Versus Switching to Indinavir (IDV) After 1 Year of Saquinavir Use
Collecte de données
Infections transmises par le sang+20
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug. Patients who are currently receiving hard capsule saquinavir are randomized to continue receiving hard capsule saquinavir or to switch to soft gelatin capsule saquinavir or indinavir. At week 8, patients receiving the hard capsule formulation will switch to open-label indinavir for weeks 8-24. Patients on the other two arms will remain on their assigned regimen for the entire 24 weeks unless they have no virologic response by week 8, in which case they will be crossed-over to open-label therapy with the alternative drug (i.e., either soft gelatin capsule saquinavir or indinavir). AS PER AMENDMENT 12/23/96: Viral RNA from weeks 16 and 24 will be assayed in batch after week 24. Patients who exhibit an antiviral response based on this assay will be allowed to continue their current drug assignment for a total of 12 months. AS PER AMENDMENT 5/7/97: Based on an interim analysis performed after 72 patients had completed 8 weeks of therapy, the study was closed as of March 7, 1997. Patients currently enrolled may stop their participation in the trial and seek other anti-retroviral therapies or may continue on study. Patients on hard capsule saquinavir who remain on study will be switched to indinavir at 8 weeks. Patients on soft gel capsule saquinavir may switch immediately to indinavir or, when results of HIV RNA and CD4 cell counts are available, may choose to switch to indinavir or remain on soft gel capsule saquinavir. Patients receiving indinavir will continue that agent. Follow-up for all patients will end on 7/4/97.
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.144 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 Concurrent Medication: Required: * PCP prophylaxis if CD4 count \<= 200 cells/mm3. Allowed: * Intralesional therapy for KS. * Vitamins. * Nucleoside RT inhibitors, provided regimen remains stable for first 8 weeks of study. Concurrent Treatment: Allowed: * Acupuncture. * Visualization techniques. Patients must have: * HIV infection. * Prior hard capsule saquinavir at 1800 mg/day for more than 1 year. Prior Medication: Allowed: * Prior saquinavir. * Prior antiretrovirals, excluding protease inhibitors other than saquinavir. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Psychological condition or medical instability that would interfere with study evaluation or procedures. AS PER AMENDMENT 5/7/97: * Active tuberculosis. Concurrent Medication: Excluded: * Protease inhibitors other than study drugs. * Non-nucleoside RT inhibitors. * Interferon. * Interleukins. * GM-CSF. * HIV vaccines. * Systemic cytotoxic chemotherapy. * Investigational drugs other than study medications. * Rifabutin. * Rifampin. * Midazolam. * Triazolam. * Ketoconazole. * Delavirdine. * Cisapride. * Terfenadine. * Astemizole. AS PER AMENDMENT 5/7/97: * Nevirapine. Patients with the following prior conditions are excluded: * Unexplained fever \> 38.5 C for any 7 days within 30 days prior to study entry. * Diarrhea persisting for 15 days within 30 days prior to study entry. Prior Medication: Excluded: * Any prior protease inhibitor other than saquinavir. Excluded within the past 2 months. * Change in antiretroviral regimen. * Systemic chemotherapy for KS. Excluded within the past month: * Non-nucleoside RT inhibitors. * Interferons. * Interleukins. * HIV vaccines. * Experimental therapies. Excluded within the past 2 weeks: * Rifabutin. * Cisapride. * Terfenadine. * Astemizole. * Midazolam. * Triazolam. * Oral ketoconazole. * Delavirdine. * Acute therapy for infection or other medical illness. Active substance abuse that would interfere with study evaluation or procedures.
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 16 sites
Ucsf Aids Crs
San Francisco, United StatesHarbor-UCLA Med. Ctr. CRS
Torrance, United StatesUniversity of Colorado Hospital CRS
Aurora, United States