Terminé

A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Zidovudine

+ Acyclovir
Médicament
Qui peut participer

HIV Infections

À partir de 13 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

Original design: The study's purpose is to compare the effects of zidovudine (AZT) alone to the combination of AZT and acyclovir (ACV) to determine if AZT/ACV is associated with a lower death rate and fewer AIDS related opportunistic infections compared to AZT alone, and to investigate the effect of these treatment plans on cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infections. The study evaluates two doses of AZT used alone versus two doses of AZT combined with ACV. Per 12/11/92 amendment: Another antiretroviral agent may be substituted for AZT. AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia. Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT. This might reduce some of the negative effects of AZT while not reducing the positive effects. AZT has been shown to increase the life span of patients with AIDS or advanced AIDS related complex and patients being treated for Pneumocystis carinii pneumonia. Drugs that increase the effectiveness of AZT against HIV may also decrease the need for high doses of AZT. This might reduce some of the negative effects of AZT while not reducing the positive effects. AMENDED: Patients are randomly assigned to one of two treatment regimens. They receive AZT (or other antiretroviral agent) with or without ACV. Treatment Plan 1: AZT along with placebo at the same time. Treatment Plan 2: AZT and ACV. Therapy is for 104 weeks with an optional extension of 24 weeks or until the end of the study whichever comes first. The maximum duration of therapy for any patient will be 128 weeks. Medication is dispensed on a biweekly basis for the first 4 weeks, then every other month for the remainder of the study. Original design: Patients are randomly assigned to one of four treatment plans to receive AZT alone or AZT and ACV. Medications are given every 4 hours (q4h) orally (PO) while awake (WA). A total of 5 doses/day are given. The per dose schedule for the four plans are: Treatment plan 1: AZT plus placebo (an inactive medication) substituting for ACV. Treatment plan 2: AZT and AZT placebo along with an ACV placebo. Treatment plan 3: AZT and ACV. Treatment plan 4: AZT and AZT placebo and ACV.

Titre officielA Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3 
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
400 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 les traitements sont administrés aux participants
Les participants sont répartis en groupes distincts, chaque groupe recevant un traitement différent en même temps. Cela permet de comparer directement l'efficacité de plusieurs traitements.

Autres façons d'administrer les traitements
Groupe unique
: tous les participants reçoivent le même traitement.

Affectation croisée
: les participants passent d'un traitement à un autre au cours de l'étude.

Plan factoriel
: les participants reçoivent des combinaisons de traitements pour évaluer leurs interactions.

Plan séquentiel
: les traitements sont administrés successivement selon un ordre prédéterminé, pouvant varier selon la réaction du participant.

Autre type d'attribution
: L'attribution des traitements ne suit pas de schéma standard ni de protocole prédéfini.

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 13 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: * Methadone maintenance. Therapies available through expanded access or treatment IND programs unless specifically excluded. * Allowed within 30 days of study entry: * Systemic steroids only if given for treatment of Pneumocystis carinii pneumonia. * Recommended: * PCP prophylaxis. Patient must have: * Recovered from first episode of histologically proven Pneumocystis carinii pneumonia (PCP) or microbiologically proven AIDS-defining opportunistic infection as defined in Centers for Disease Control HIV classification group IV. * C-1. * Study entry must be within 120 days of AIDS-defining diagnosis. * Written documentation of positive antibody to HIV by any federally licensed ELISA test kit. This test should be confirmed by another method, for example, Western blot, radioimmunoassay (RIA), HIV culture. * Patients cannot be transfusion dependent (requiring blood transfusion more than once per month). The last transfusion must be \> 2 weeks before entry. * AMENDED 90-08-27 to include HIV positive patients with CD4+ count \< 200 cells/mm3. Prior Medication: Allowed: * Zidovudine (AZT) for \< 365 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by \> 10 new lesions in the 30 days prior to entry). * Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled). * Malabsorption as defined by persistent diarrhea \> 6 stools/day for \> 4 weeks. Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C. Concurrent Medication: Excluded: * Acyclovir (ACV) prophylaxis or frequent (\> once per month) repeated courses of ACV therapy for herpes simplex virus infection. * Any concomitant medicine unless required. * Systemic therapy/prophylaxis/maintenance for AIDS-defining opportunistic infection other than prophylaxis for Pneumocystis carinii pneumonia (PCP). * Acetaminophen for \> 72 hours. Cimetidine. * Flurazepam. * Indomethacin. * Ranitidine. * Probenecid (if receiving AZT). * Rifampin. * Rifampin-related drugs. Patients with the following are excluded: * Active opportunistic infections. * Symptomatic visceral or progressive Kaposi's sarcoma (KS) (defined by \> 10 new lesions in the 30 days prior to entry). * Other concurrent neoplasms other than basal cell carcinoma of skin (patients who have been in complete remission for 1 year for a malignancy may be enrolled). * Malabsorption as defined by persistent diarrhea \> 6 stools/day for \> 4 weeks. * Patients whose sole AIDS-defining condition is constitutional disease as defined in CDC's HIV group IV-A or neurologic disease as defined in CDC's HIV group IV-B or AIDS-associated malignancies as defined in CDC's HIV group IV-C. Prior Medication: Excluded: * Zidovudine (AZT) for \> 365 days prior to study entry. * Excluded within 14 days of study entry: * Systemic acyclovir (ACV) therapy. * Excluded within 30 days of study entry: * Antiretroviral therapy (other than AZT per above). * Immunomodulating agents. * Biologic response modifiers. Excluded within 60 days of study entry: * Ribavirin. Prior Treatment: Excluded within 30 days of study entry: * Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma. Active substance abuse that would impair compliance with study procedure.



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
Suspendu
Bmc Actg CrsBoston, United StatesVoir le site
Suspendu
Beth Israel Deaconess - East Campus A0102 CRSBoston, United States
Suspendu
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, United States
Suspendu
Massachusetts General Hospital ACTG CRSWorcester, United States

Terminé8 Centres d'Étude