A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy
Collecte de données
Infections transmises par le sang+13
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs. Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly with ddI will start with AZT, while the other half will start with ddI. Treatment continues until death or termination of the study. Patients are followed every 4 weeks. The study will include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic assessments will be made.
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.654 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 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: Required: * PCP prophylaxis. Allowed: * Erythropoietin. * Prophylaxis for MAI or fungal infections. * Antibiotics. * Over-the-counter, alternative, or regularly prescribed drugs. * Steroids, if for \< 21 days. Concurrent Treatment: Allowed: * Radiation therapy for cutaneous Kaposi's sarcoma. Patients must have: * HIV infection. * CD4 count \<= 50 cells/mm3. * Prior nucleoside monotherapy for at least 6 months. * Life expectancy of at least 6 months. Prior Medication: Required: * Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Severe peripheral neuropathy. * Psychological or emotional problems sufficient to prevent study compliance. Concurrent Medication: Excluded: * Systemic chemotherapy for malignancy. * Acute or induction therapy for opportunistic infection. Patients with the following prior conditions are excluded: * History of acute or chronic pancreatitis. * Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. Prior Medication: Excluded: * Non-study nucleosides or biologic response modifiers within 7 days prior to study entry. * Acute therapy for opportunistic process within 14 days prior to study entry. * Acute systemic therapy for other medical conditions within 14 days prior to study entry.
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 37 sites
Memorial Sloan-Kettering Cancer Ctr.
New York, United StatesUniv. of Rochester ACTG CRS
Rochester, United StatesUnc Aids Crs
Chapel Hill, United States