An Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients
Abacavir sulfate
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Patients will all receive oral doses of 1592U89 in combination with protocol specific current antiretroviral therapy. The treatment groups will be assigned based on each subject's previous NRTI experience. The study medication is self administered and all evaluations will be performed on an outpatient basis. Patients will be seen at day 0 and weeks 2, 4, 12, 16, 20 and 24.
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.40 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 Patients must have: CD4+ cell count >= 100 /mm3. Plasma HIV RNA >= 30,000 copies/ml. Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria. Parent or legal guardian to sign written, informed consent for patients under the age of 18. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE: For this study, a CD4+ cell count <= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event. Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption. Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety. Concurrent Medication: Excluded: Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study. Patients receiving other investigational drugs. Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro. Treatment with immunomodulators. Patients on methadone. Concurrent Treatment: Excluded: Treatment with radiation therapy within the 24 weeks of the study. NOTE: Localized radiation therapy may be permitted following consultation with the sponsor. Patients with any of the following prior conditions are excluded: Subjects with a history of lymphoma. Subjects with a history of clinically apparent pancreatitis or hepatitis within the last 6 months. Prior Medication: Excluded: Treatment with any antiretroviral therapy with NRTIs (alone or in combination) other than those defined for each treatment group. Treatment with any non-nucleoside RT inhibitors or protease inhibitors. Treatment with cytotoxic chemotherapeutic agents within 1 month prior to study entry. Investigational HIV vaccine within the past 3 months. Immunomodulating agents such as systematic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry. Prior Treatment: Excluded: Treatment with radiation therapy within 1 month of entry. Risk Behavior: Excluded: Patients with current alcohol or illicit drug use that, in the opinion of the principal investigator, may interfere with the patient's ability to comply with the study protocol.
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 8 sites
Marin County Specialty Clinic
Greenbrae, United StatesOuvrir Marin County Specialty Clinic dans Google MapsKraus Med Partners
Los Angeles, United StatesViRx Inc
San Francisco, United StatesIDC Research Initiative
Altamonte Springs, United States