A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3
Zidovudine
+ Didanosine
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period. Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.
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.105 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: Allowed: Antibiotics for bacterial infections as clinically indicated. Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively. Antipyretics. Analgesics. Allergy medications. Oral contraceptives. Nonprescription medications such as vitamins or herbal therapies. Concurrent Treatment: Allowed: Radiation therapy to local lesion only. Acupuncture. Patients must have: HIV seropositivity. CD4 count >= 550 cells/mm3. No ARC or AIDS conditions by CDC criteria. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Presence of factors predisposing to pancreatitis such as active alcoholism. Other medical conditions that would interfere with study compliance. Concurrent Medication: Excluded: Other antiretrovirals or systemic immunomodulators. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Radiation therapy except to local lesion. Patients with the following prior conditions are excluded: History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month. History of grade 2 or worse peripheral neuropathy. History of pancreatitis. Bacterial infection requiring antibiotics within 14 days prior to study entry. Prior Medication: Excluded: Prior HIV therapy with antiretrovirals or systemic immunomodulators. Prior Treatment: Excluded within 2 weeks prior to study entry: Transfusion. Active substance abuse or alcoholism.
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 7 sites
Hennepin County Med Clinic
Minneapolis, United StatesOuvrir Hennepin County Med Clinic dans Google MapsUniv of Minnesota
Minneapolis, United StatesSt Paul Ramsey Med Ctr
Saint Paul, United StatesUniv of Nebraska Med Ctr
Omaha, United States