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A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems

A Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses

To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood.

RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).

Patients are selected from three patient groups:

  • Patients with AIDS, who have not taken zidovudine (AZT) within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance.
  • Patients with AIDS related diseases who have not taken AZT within 30 days of entry into the study, and who have not been discontinued from AZT because of intolerance.
  • Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy. This is an outpatient study; patients are seen weekly for the first 4 weeks, every other week through week 12, and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study. Patients from each of the three diagnostic groups are enrolled at each dose level. For the first 3 days after entry into the study, all patients receive the lowest dose of RBV every 6 hours. Subsequent dosages increase until the maximum tolerated dose (MTD) is reached. The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage.

Patients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance.

Type d'étude

Interventionnel

Inscription

96

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • San Diego, California, États-Unis, 921036325
        • Univ of California / San Diego Treatment Ctr
      • San Francisco, California, États-Unis, 941102859
        • San Francisco AIDS Clinic / San Francisco Gen Hosp
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Harvard (Massachusetts Gen Hosp)
    • New York
      • New York, New York, États-Unis, 10016
        • Bellevue Hosp / New York Univ Med Ctr
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 275997215
        • Univ of North Carolina

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Short-course therapy (7 days) with oral acyclovir.
  • Short-course therapy (7 days) with ketoconazole.
  • Topical medications.
  • Aerosolized pentamidine for prophylactic purposes.

Concurrent Treatment:

Allowed:

  • Blood transfusions for hemoglobin toxicity.

Patients must have two positive HIV p24 antigen tests with titers = or > 70 picograms at least 72 hours apart and within 1 month prior to entry, the last of which must be within 2 weeks of starting therapy.

Prior Medication:

Allowed:

  • Zidovudine (AZT), without cessation of therapy required due to intolerance.
  • AZT therapy must be discontinued at least 30 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or > 3 liquid stools per day within the past week.

Concurrent Medication:

Excluded:

  • Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
  • Antineoplastic therapy.
  • Other experimental medications.
  • Systemic chemoprophylaxis for Pneumocystis carinii pneumonia.
  • Chronic (> 7 days) oral acyclovir therapy.

Concurrent Treatment:

Excluded:

  • Blood transfusions unless they are for = or > grade 3 hemoglobin toxicity.

Patients with the following are excluded:

  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or > 3 liquid stools per day within the past week.

Prior Medication:

Excluded within 30 days of study entry:

  • Antiretroviral agents including zidovudine (AZT).
  • Biologic modifiers.
  • Systemic corticosteroids.

Prior Treatment:

Excluded within 2 months of study entry:

  • Blood transfusion except for those who have taken zidovudine (AZT) who may not have received a transfusion within the previous month.

Active drug or alcohol abuse.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Masquage: Aucun (étiquette ouverte)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Crumpacker C

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • Crumpacker C, Pearlstein G, van der Horst C, Valentine F, Spector S, Mills J. A phase one increasing dose trial of oral ribavirin (RBV) in patients with AIDS and ARC. Int Conf AIDS. 1990 Jun 20-23;6(3):203 (abstract no SB468)
  • Crumpacker C, Cotton D, Pearlstein G, Valentine F, Mills J, Spector S. Ribavirin dose escalating phase 1 trial in patients with AIDS and ARC. Int Conf AIDS. 1989 Jun 4-9;5:336 (abstract no TBP296)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Achèvement de l'étude (Réel)

1 juin 1990

Dates d'inscription aux études

Première soumission

2 novembre 1999

Première soumission répondant aux critères de contrôle qualité

30 août 2001

Première publication (Estimation)

31 août 2001

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 novembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 octobre 2021

Dernière vérification

1 octobre 2021

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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