Évaluation de l'activité anti-VIH du Delavirdine Mesylate chez les patients séropositifs
Cette étude vise à évaluer la sécurité et l'efficacité du Delavirdine Mesylate en tant que traitement contre le VIH chez les individus séropositifs.
Delavirdine mesylate
+ Zidovudine
+ Didanosine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors. Patients are randomized to receive U-90152 at one of three doses (treatment arms I through III) or either AZT or ddI (treatment arm IV). Patients on arm IV who are AZT-naive receive AZT; those who are AZT-experienced receive ddI. Treatment continues for 24 weeks. PER 12/22/94 AMENDMENT: All patients receiving U-90152 have the same starting dose, to attain one of three target trough levels.
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.120 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: Allowed: PCP prophylaxis. Topical antifungal agents, clotrimazole troches, nystatin oral suspension, topical ketoconazole, and oral fluconazole. Acyclovir (<= 1000 mg/day) as maintenance therapy for herpes simplex virus. Recombinant erythropoietin and G-CSF. Antibiotics for bacterial infections, unless specifically excluded. Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics. Antacids. Patients must have: HIV-1 infection. CD4 count 200 - 500 cells/mm3. Either no prior antiretroviral therapy or discontinued AZT monotherapy 3 or more weeks prior to study entry. NOTE: Half of patients should be antiretroviral naive. Prior Medication: Allowed: Prior AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy other than minimal Kaposi's sarcoma. Concurrent Medication: Excluded: Rifabutin. Rifampin. Terfenadine. Astemizole. Loratadine. Trifluoperazine. Piperazine citrate. Any acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection. Non-study antiretroviral therapies, interferons, biologic response modifiers, and HIV vaccines. Systemic corticosteroids for more than 21 consecutive days. Foscarnet. Systemic cytotoxic chemotherapy for a malignancy. Patients with the following prior conditions are excluded: History of pancreatitis (in patients who received prior AZT). History of grade 2 or worse peripheral neuropathy (in patients who received prior AZT). History of hypersensitivity to BHAP compounds (e.g., trifluoperazine - Stelazine, piperazine citrate - Antepar). Prior Medication: Excluded within 30 days prior to study entry: Any investigational medication. Interferon. Interleukin. Rifabutin. Rifampin. Terfenadine. Astemizole. Loratadine. Trifluoperazine. Piperazine citrate. Excluded at any time: Prior ddI, ddC, d4T, or 3TC. Prior foscarnet. Prior BHAP compound or other non-nucleoside RT inhibitor. Active substance abuse interfering with compliance.
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 10 sites
University of Colorado Hospital CRS
Aurora, United StatesHoward University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., United StatesUniv. of Miami AIDS CRS
Miami, United States