A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3
Saquinavir
+ Zidovudine
+ Zalcitabine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.
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.3000 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: Erythropoietin and G-CSF. Concurrent Treatment: Allowed: Local skin radiotherapy. Patients must have: HIV infection. CD4 count 50 - 350 cells/mm3. No prior antiretroviral therapy OR less than 16 weeks of prior AZT. No acute serious opportunistic infections requiring immediate treatment. No unexplained fever persisting for 14 days within 90 days prior to study entry. No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. Life expectancy of at least 80 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption. Severe chronic diarrhea. Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). Any grade 3 or worse toxicity. Inability to comply with study requirements. Concurrent Medication: Excluded: Other investigational agents. Antineoplastic agents. Biologic response modifiers (including interferons). Foscarnet. Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded: Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded: Acute therapy for opportunistic infection within 14 days prior to study entry. Prior HIV proteinase inhibitor.
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 26 sites
UCD Med Ctr
Sacramento, United StatesDavies Med Ctr
San Francisco, United StatesMount Zion Med Ctr / UCSF
San Francisco, United States