A Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections
Anti-HIV Immune Serum Globulin (Human)
+ Zidovudine
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease. Participants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone.
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.112 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.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: Recommended: Standard immunizations. Should repeat MMR 3 months after discontinuing study. Benadryl and/or aspirin. Pneumocystis carinii pneumonia prophylaxis. Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy. Aerosol ribavirin for short-term treatment of RSV. Concurrent Treatment: Allowed: Blood transfusion. Patients must have the following: Parent or guardian available to give written informed consent. Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study. Prior Medication: Allowed: Gammaglobulin, intravenous (IV) or intramuscular (IM). Immunoglobulin, IV (IVIG). Maternal antiretroviral treatment during pregnancy. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. Presence of serious acute infection requiring parenteral treatment at time of study entry. Concurrent Medication: Excluded: Prophylaxis for oral candidiasis or otitis media or other infections. Immunoglobulin therapy (except single dose or for hypogammaglobulinemia). Ketoconazole, acyclovir, or nystatin for prophylaxis. Patients with the following are excluded: Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. Presence of serious acute infection requiring parenteral treatment at time of study entry. Prior Medication: Excluded: Antiretroviral treatment or experimental treatment within 2 weeks of entry.