Terminé

(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC

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Ce qui est testé

Zidovudine

+ Zalcitabine
Médicament
Qui peut participer

HIV Infections

À partir de 18 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 : 14 mars 2011
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a different safety profile than AZT. In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted. In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted. After screening, physical examination and laboratory tests (within 14 days of entry) patients are randomized to one of two treatment groups. They receive either ddC plus an AZT placebo or AZT plus a ddC placebo. Because it is a blinded study, patients do not know which group they are in. Patients are evaluated weekly for the first 10 weeks and then biweekly thereafter.

Titre officiel(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 14 mars 2011
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
600 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.

Comment la nature du traitement est tenue confidentielle
Dans une étude en double aveugle, ni les participants ni les chercheurs ne savent quel traitement est administré. C'est la méthode la plus rigoureuse pour éviter tout biais lié aux attentes et garantir des résultats fiables.

Autres méthodes de masquage
En ouvert
: tout le monde connaît le traitement administré.

Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

Triple aveugle
: Les participants, les chercheurs et les personnes qui analysent les résultats ne savent pas quel traitement est administré.

Quadruple aveugle
: Les participants, les chercheurs, les personnes qui analysent les résultats et les professionnels de santé en charge du suivi ne savent pas non plus quel traitement est administré.

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 18 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: Allowed: * Aerosolized pentamidine (300 mg once every 4 weeks) for Pneumocystis carinii pneumonia (PCP) prophylaxis. * Neuroleptics, benzodiazepines, or antidepressants if patient has been stable with chronic treatment \> 1 month. * Low dose benzodiazepines or low dose antidepressants. * Drugs that are unlikely to cause increased toxicity with either study drug and are unlikely to cause peripheral neuropathy. * Drugs with little nephrotoxicity, hepatotoxicity, or cytotoxicity that the patient has been taking and tolerating well. * Acyclovir (up to 600 mg/kg/day) for up to 21 days. * Ketoconazole (up to 400 mg/day) Nystatin. * Low-dose acetaminophen or nonsteroidal anti-inflammatory agents. * Isoniazid if patient has no evidence of peripheral neuropathy at entry and if patient takes 50 mg/day pyridoxine concomitantly with isoniazid. * Allowed with interruption of study medication for up to 21 days per episode and for a total of 42 days for the study: * Drugs that could cause serious additive toxicity when coadministered with either study medication for treatment of an acute intercurrent illness or opportunistic infection, including: * Acyclovir (\< 600 mg/day), fluconazole, systemic pentamidine, foscarnet, pyrimethamine, triple sulfa, ansamycin, ganciclovir, trimethoprim / sulfamethoxazole. Patients must have a diagnosis of AIDS or advanced AIDS related complex (ARC). At least 20 percent of the patients must have a consistently positive serum HIV p24 antigen (= or \> 70 pg/ml) as defined by the Abbott HIV antigen test, on two separate occasions at least 72 hours apart. * Patients found at screening to have a temperature \> 38.5 degrees C should be evaluated for the possibility of an occult opportunistic or bacterial infection or neoplasm. If this complete evaluation reveals an infection, they can be entered. If this evaluation is unrevealing, they may be entered after evaluation is completed but while mycobacterial cultures are still pending. Patients with a history of unexplained temperatures \> 38.5 degrees C should be evaluated as above and/or be afebrile (temperature \< 38.0 degrees C) for 2 weeks prior to study entry. * Allowed: Kaposi's sarcoma not specifically excluded, basal cell carcinoma of the skin or in situ carcinoma of the cervix. * Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) if treated as for asymptomatic neurosyphilis. Prior Medication: Allowed: * Drugs that cause peripheral neuropathy and drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC) including experimental drugs if therapy with these drugs is completed and patient is stable for 14 days. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Active AIDS defining opportunistic infection or other active intercurrent illness is excluded if ongoing treatment requires the use of excluded concomitant medication. * Patients with symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with current neoplasms not specifically allowed. * Severe AIDS dementia complex defined by a score of \< 23 on the Mini-Mental State Exam. * Signs, symptoms, or history of peripheral neuropathy. * Significant cardiac disease, defined as history of ventricular arrhythmias requiring medication, prior myocardial infarct, or history of angina or ischemia changes on ECG (electrocardiography). * Requiring \> 2 weeks of acyclovir therapy at \> 600 mg/day. * Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) not specifically allowed. * Significant liver disease. Concurrent Medication: Excluded: * Drugs that cause peripheral neuropathy: * chloramphenicol, cisplatinum, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, ribavirin, metronidazole, vincristine, nitrofurantoin. * Drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC), including experimental drugs not specifically allowed. * Drugs that could cause seizures or changes in mental status or neurological examination. Concurrent Treatment: Excluded: * Transfusion dependency. Patients with the following are excluded: * Active AIDS defining opportunistic infection or other active intercurrent illness if ongoing treatment requires use of excluded concomitant medication. * Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or current neoplasms not specifically allowed. * Severe AIDS dementia complex defined by a score of \< 23 on the Mini-Mental State Exam. * Signs, symptoms, or history of peripheral neuropathy. * Unwilling or unable to sign informed consent. Prior Medication: Excluded: * Zidovudine (AZT), dideoxycytidine (ddC), or any other antiretroviral nucleoside analog. * Excluded within 90 days of study entry: * Any experimental drug including fluconazole, ganciclovir, foscarnet, erythropoietin, or ribavirin. Excluded within 90 days of study entry: * Drugs that have caused significant nephrotoxicity or significant hepatotoxicity. * Drugs that could cause peripheral neuropathy including phenytoin, hydralazine, metronidazole, and nitrofurantoin. * Systemic corticosteroids or immunomodulators including interferon and interleukin. Prior Treatment: Excluded within 30 days of study entry: * Radiation therapy. Active substance or alcohol 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 25 sites
Suspendu
Kaiser Foundation HospHarbor City, United StatesVoir le site
Suspendu
Kaiser Permanente Med CtrLos Angeles, United States
Suspendu
UCD Med CtrSacramento, United States
Suspendu
Davies Med CtrSan Francisco, United States

Terminé25 Centres d'Étude