Terminé

A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients

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Ce qui est testé

Pentamidine isethionate

+ Sulfamethoxazole-Trimethoprim
+ Dapsone
Médicament
Qui peut participer

Pneumonia, Pneumocystis Carinii

+ HIV Infections
À partir de 13 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 3
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 evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis. All patients receive AZT. In addition, they are placed in one of three groups to receive either SMX/TMP, dapsone, or PEN. Stratification criteria are: Received first AZT equal to or less than 6 weeks prior to study entry. Received first AZT more than 6 weeks prior to study entry. Potential to participate in ACTG 981. ACTG center in which the patient is enrolled.

Titre officielA Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection 
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
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 ouvert, tous les participants ainsi que les chercheurs savent quel traitement est administré. Ce type de protocole est utilisé lorsqu'il n'est pas nécessaire ou pas possible de masquer les traitements.

Autres méthodes de masquage
Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

Double aveugle
: ni les participants ni les chercheurs ne savent quel traitement est administré.

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 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
Pneumonia, Pneumocystis Carinii
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Allowed: * Antifolate medication required to treat an intercurrent infection. * Treatment of intercurrent infections or malignancies. * Fluconazole. * Itraconazole. * Standard or investigational therapy for pneumocystosis (PCP) or toxoplasmosis. * Only the forms of primary prophylaxis for PCP or toxoplasmosis assigned to the participant under the protocol. Patients who develop intolerance to all forms of prophylaxis assigned in this protocol or who develop PCP or toxoplasmosis may receive alternate or investigation forms of prophylaxis with or without zidovudine but must continue to be followed under this protocol. * Discouraged but allowed: AL-721. * Chronic acyclovir. * Ketoconazole. * Amphotericin B. * Corticosteroids at greater than physiologic replacement doses are strongly discouraged. * They should be used as briefly as possible and only for definite specific indications. Patient must conform to the following: * Receiving or candidates for zidovudine therapy at least 500 mg/day under current labeled indications with no history of pneumocystosis (PCP) or toxoplasmosis. * Evidence of HIV infection documented by HIV antibody tests. * T4 cell count less than 200 cells/mm3 at any time prior to study entry. * Willing to sign informed consent. * Willing to be followed by a participating ACTG center for duration of the study. * Allowed: Concurrent enrollment in long-term follow-up studies in previously blinded trials of AZT (ACTG 016 and 019). Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: * History of documented or presumed pneumocystosis (PCP) or toxoplasmosis. * Active bacterial or mycobacterial infection. * History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. * History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 600 mg/day or causing dose reduction to less than 500 mg/day within 4 weeks prior to entry. * Advanced Kaposi's sarcoma or other malignancy not specifically allowed that has been rapidly progressive during the month prior to enrollment or which may be expected to require chemotherapy within 90 days of study entry. Concurrent Medication: Excluded: * Active primary treatment for an infection or malignancy. * Other form of antifolate medication not specifically allowed. * Other antiretroviral or biologic response modifier. * Ganciclovir, if it causes intolerance to AZT equal to or more than 500 mg/day. * Foscarnet. Patients with the following are excluded: * Symptoms and conditions defined in Exclusion Coexisting Conditions. * Glucose 6-phosphate dehydrogenase deficiency (GPD). * History of pneumocystosis (PCP) or toxoplasmosis. * History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. * History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 500 mg/day with 4 weeks pior to study entry. Prior Medication: Excluded within 4 weeks of study entry: * Any other form of pneumocystosis (PCP) chemoprophylaxis. * Active substance abuse, including alcohol.



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 21 sites
Suspendu
USC CRSLos Angeles, United StatesVoir le site
Suspendu
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.Oakland, United States
Suspendu
Ucsd, Avrc CrsSan Diego, United States
Suspendu
Univ. of Miami AIDS CRSMiami, United States

Terminé21 Centres d'Étude