A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance
Zidovudine
+ Didanosine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors. One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1) continue with AZT, 2) switch to treatment with didanosine at 1 of 2 doses, or 3) receive both AZT and ddI. Treatment is given for 16 weeks, with a possible extension to 32 weeks. Patients are followed at weeks 2, 4, 8, 12, and 16. For analysis purposes only, patients are stratified according to degree of susceptibility of HIV isolates to AZT.
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.120 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 12 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: Chemoprophylaxis against Pneumocystis carinii pneumonia (PCP), Mycobacterium tuberculosis, or Herpes simplex virus, or against other opportunistic infections as indicated. Corticosteroids for no longer than 21 days (only as part of PCP therapy). Erythropoietin and G-CSF. Patients must have: Documented HIV-seropositivity. CD4 count 100 - 300 cells/mm3. Prior continuous AZT dose = or > 300 mg/day for 1 year or longer. Prior Medication: Required: AZT for at least 1 year prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Medical contraindication or is considered noncompliant in the opinion of the investigator. Peripheral neuropathy = or > grade 2. Concurrent Medication: Excluded: Anti-HIV agents other than study drugs. Biologic response modifiers (other than erythropoietin or G-CSF). Systemic cytotoxic chemotherapy. Regularly prescribed medications (such as antipyretics, analgesics, allergy medications) that are associated with an increased risk of pancreatitis, peripheral neuropathy, or bone marrow suppression. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis, gout, or uric acid nephropathy. Prior Medication: Excluded: Other antiretrovirals besides AZT. ddI or ddC for more than 30 days within the past year or any time within 3 months prior to study entry. Acute therapy for an infection or other medical illness 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 18 sites
Univ of Alabama at Birmingham
Birmingham, United StatesOuvrir Univ of Alabama at Birmingham dans Google MapsSan Francisco Gen Hosp
San Francisco, United StatesSanta Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, United StatesSan Mateo AIDS Program / Stanford Univ
Stanford, United States