A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
Collecte de données
Infections transmises par le sang+17
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus. Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis B vaccination) that would be expected to induce a nonspecific immune response in HIV-infected persons. Fifty-five healthy HIV-positive volunteers are randomly assigned to one of the following treatment arms: six injections (arm I) or four injections (arm II) of HIV-1 gp160 vaccine, four injections of hepatitis B vaccine as a non-HIV viral vaccine control (arm III), or six placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine (arm IV). Immunizations or placebo are given at 4-week intervals for 5 months. To maintain blinding, adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving four instead of six vaccine injections (arms II and III). Volunteers are followed at 4-month intervals for 2 years.
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.55 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 60 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: Recommended: * Prophylaxis with isoniazid in patients not previously treated. Patients must have: * HIV seropositivity by Western blot. * Normal history and physical exam (generalized lymphadenopathy is acceptable). * Mean CD4 cell count = or \> 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count \< 450 cells/mm3. * Negative PPD test or normal chest x-ray with positive PPD (induration = or \> 5 mm). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Hepatitis B surface antigen positive. * Evidence of an AIDS- or ARC-defining opportunistic infection. * Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month. * Active syphilis. Patients with the following prior conditions are excluded: * Evidence of psychiatric disorder within the past year that would impair adherence to the protocol. * History of an AIDS- or ARC-defining opportunistic infection. * History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month. Prior Medication: Excluded: * Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening. * Immunosuppressive medications within the previous 3 months. * Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months. * Vaccination against other pathogens within 4 weeks of initial screening laboratory work. Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study 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 2 sites
Johns Hopkins Adult AIDS CRS
Baltimore, United StatesOuvrir Johns Hopkins Adult AIDS CRS dans Google MapsWashington U CRS
St Louis, United States