Terminé

Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

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Ce qui est testé

Lamivudine

+ Stavudine
+ Zidovudine
Médicament
Qui peut participer

HIV Infections

À partir de 12 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone. Patients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDMENT 8/27/96: The study has been extended 6 months and treatment will be available until March 15, 1997 at the latest. Each patient will have regularly scheduled 12 week safety visits during the extension period. AS PER AMENDMENT 1/22/97: The study has been extended for approximately 16 additional weeks beyond the current 6-month extension. Subjects will be unblinded to their assigned regimen beginning 2/21/97 and will continue therapy for up to 16 weeks in open-label fashion. AS PER AMENDMENT 5/9/97: The study has been extended for an additional 8 weeks; study drug will not be provided after 9/15/97.

Titre officielVirologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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.
Détails du design
280 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 12 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Recommended: * PCP prophylaxis in patients with CD4 count \<= 200 cells/mm3. Allowed: * Chemophylaxis against Mycobacterium tuberculosis. * Acyclovir. * Vaccination with pneumococcal vaccine polyvalent. * Haemophilus B Conjugate vaccine. * Chemoprophylaxis for MAC and Toxoplasma gondii. * Antibiotics. * Recombinant erythropoietin ( EPO ) and G-CSF. * Systemic corticosteroids for \< 21 days. * Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives. * Vitamins and herbal therapies. Concurrent Treatment: Allowed: * Limited local radiation therapy to skin. * Blood transfusions if 3 units or less per 21-day period. * Acupuncture. * Visualization techniques. Patients must have: * Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval. * Not reached an ACTG 175 endpoint prior to May 1, 1995. * Consent of parent or guardian if less than 18 years old. PER AMENDMENT 8/27/96: * Patients must be on study/on treatment at the time the protocol study treatment is extended. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Grade 2 or worse peripheral neuropathy. * Malignancy requiring systemic therapy. Concurrent Medication: Excluded: * Anti-HIV drugs other than study drugs. * Biologic response modifiers. * Systemic cytotoxic chemotherapy. * Any drug known to affect glucuronidation and/or clearance of AZT. Concurrent Treatment: Excluded: * Radiation therapy other than limited local therapy to skin. Patients with the following prior condition are excluded: * History of acute or chronic pancreatitis. Prior Medication: Excluded: * Prior 3TC. * Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry. Current ethanol abuse.



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 40 sites
Suspendu
Alabama Therapeutics CRSBirmingham, United StatesVoir le site
Suspendu
USC CRSLos Angeles, United States
Suspendu
UCLA CARE Center CRSLos Angeles, United States
Suspendu
Stanford CRSPalo Alto, United States

Terminé40 Centres d'Étude