A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
Collecte de données
Infections transmises par le sang+13
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV. The immune system fights infections in the human body, and the HIV attacks T cells that are an important part of the immune system. Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients, but there is no reliable information on the safety and effectiveness of this drug combination in such patients. All patients take INPX capsules 4 times a day and RBV capsules 2 or 3 times a day. The first group of patients take the dose of RBV shown to be effective in an earlier trial and subsequent groups take higher doses until toxic effects occur. The planned treatment period is 3 months, but further treatment may be allowed for patients showing improvement. Blood samples are taken from an arm vein and used to evaluate possible changes in the patient's immune system, any toxic effects that might be detected in the blood and possible changes in the presence of HIV in the blood.
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.20 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.De 18 à 75 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 * It must be possible to culture HIV from peripheral blood lymphocytes on 2 consecutive screenings within 2 months of starting treatment. Concurrent Medication: Allowed: * Systemic medications not listed in the Exclusion Concurrent Medications field considered necessary for the patient's medical management and which would not interfere with the study may be used, but such use must be documented. Exclusion Criteria Concurrent Medication: Excluded: * Systemic steroids. * Cytotoxic immunosuppressive medications. * Any systemic experimental anti-HIV drug such as dideoxycytidine (ddC), foscarnet, ribavirin, isoprinosine, or zidovudine (AZT). * Any other medication felt to be immunomodulatory or felt to exhibit significant hepatotoxicity or hematologic or renal toxicity by study investigators. Prior Medication: Excluded within 6 weeks of study entry: * Systemic steroids. * Cytotoxic immunosuppressive medications. * Any systemic experimental anti-HIV drug such as dideoxycytidine (ddC), foscarnet, ribavirin, isoprinosine, or zidovudine (AZT). * Any other medication felt to be immunomodulatory or felt to exhibit significant hepatotoxicity or hematologic or renal toxicity by study investigators. Current active infections, known cardiac disease, or prior history of one of the following: * Gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction. * Neoplasms: * Other than locally treated basal or squamous carcinoma. * Cardiovascular: * Myocardial infarction, cardiac arrhythmia, cardiomyopathy, or congestive heart failure. Past or current history of CDC-defined AIDS including HIV encephalopathy and HIV wasting syndrome. Constitutional symptoms (CDC Group IV-A), neurologic symptoms (CDC Group IV-B), or any prior or current non-AIDS defining secondary infectious disease (CDC Group IV-C2). Grade 1 impairment on 2 or more items in the ACTG Micro Neuro-AIDS Assessment. Active drug or alcohol abuse.
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 1 site
George Washington Univ Med Ctr
Washington D.C., United StatesOuvrir George Washington Univ Med Ctr dans Google Maps