A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
Collecte de données
Infections transmises par le sang+13
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies. Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.
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.130 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
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 13 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: * Short-term nonsteroidal anti-inflammatory therapy. Patients must have: * HIV seropositivity. * CD4 count \>= 500 cells/mm3. * Successful establishment of EBV-transformed B-cell lines at study entry. * Consent of parent or guardian if \< 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Suspected or known allergies to any vaccine components. * Medical contraindication. * Problem with compliance. Concurrent Medication: Excluded: * Antiretroviral therapy (e.g., AZT, ddI, or ddC). * Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin). * Parenteral therapies (including SC allergy sensitization). * Other investigational HIV drugs or therapies. Prior Medication: Excluded: * Any prior vaccinations against HIV. * Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months. * Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months. * Parenteral therapies (including SC allergy sensitization) within the past 3 months. * Other investigational HIV drugs or therapies within the past 3 months.
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
Stanford CRS
Palo Alto, United StatesSanta Clara Valley Med. Ctr.
San Jose, United StatesSan Mateo County AIDS Program
San Mateo, United States