A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3
Interferon alfa-2a
+ Zidovudine
+ Zalcitabine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects. Patients are randomly assigned to one of three treatment arms to receive AZT/ddC alone or combined with one of two doses of IFN alfa-2a. Treatment continues for up to 12 months after enrollment of the last patient. Patients are followed at 2, 4, and 8 weeks and every 8 weeks thereafter. Mean duration of follow-up is expected to be 13 months.
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.60 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: Isoniazid for < grade 2 peripheral neuropathy (if patient is also taking 50 mg/day pyridoxine). Phenytoin for < grade 2 peripheral neuropathy. A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe Pneumocystis carinii pneumonia (PCP). Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir daily), and Mycobacterium tuberculosis. Patients must have: HIV infection. CD4 count < 400 cells/mm3 within 30 days prior to study entry. NOTE: Minimal Kaposi's sarcoma is allowed. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Active opportunistic infection requiring acute therapy. Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis, or mycobacterial infection. Malignancy (other than minimal Kaposi's sarcoma) requiring therapy. Grade 2 or worse peripheral neuropathy. Concurrent Medication: Excluded: Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or investigational drugs (unless approved by the protocol chairs). Recombinant erythropoietin, G-CSF, or GM-CSF. Drugs that cause peripheral neuropathy, e.g., gold, hydralazine, nitrofurantoin, vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the protocol chairs). Concurrent Treatment: Excluded: Radiation therapy (unless approved by the protocol chairs). Patients with the following prior conditions are excluded: History of intolerance to AZT at 600 mg/day or less. Unexplained temperature of 38.5 degrees C persisting for 14 days or longer. Unexplained, chronic diarrhea defined as 3 or more stools per day persisting for 14 days or longer. Prior Medication: Excluded: Acute therapy for opportunistic infection within 14 days prior to study entry. Prior ddC, ddI, or IFN alfa-2a. Active substance 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 4 sites
Ucsd, Avrc Crs
La Jolla, United StatesUCSD Maternal, Child, and Adolescent HIV CRS
San Diego, United StatesUniv. of Miami AIDS CRS
Miami, United States