Terminé

A Controlled Comparative Trial of Trimethoprim - Sulfamethoxazole Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)

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Ce qui est testé

Pentamidine isethionate

+ Pyrimethamine

+ Sulfamethoxazole/Trimethoprim

Médicament
Qui peut participer

Infections transmises par le sang+28

+ Maladies génito-urinaires

+ Maladies Génitales

À partir de 12 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 3
Interventionnel
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 3 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate. The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone. Patients receive the standard dose of AZT at study entry. Low body weight patients receive AZT at a lower dose. Patients are randomly assigned to one of two medications intended to prevent the recurrence of PCP. Patients assigned to SMX/TMP will take 1 capsule which contains both drugs once a day for 1 year. Patients assigned to PEN will have 1 aerosol treatment every 4 weeks for 1 year. Blood will be drawn at intervals in order to estimate blood levels of the drugs and to detect any adverse effects from the drugs. Note: Earlier versions of this protocol reflect its original design as a 3-arm study comparing aerosolized PEN, SMX/TMP, and pyrimethamine-sulfadoxine as secondary prophylaxis of PCP in AIDS patients receiving AZT. In order to reduce the effective sample size and permit the completion of accrual in a reasonable period of time, the pyrimethamine - sulfadoxine arm of this study has been discontinued. Patients randomized to this arm will be continued in this study on the original randomized therapy. Management of these patients will follow that described for SMX/TMP in the latest protocol version. AMENDED: Lower dose of AZT allowed.

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 3 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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

322 participants à inclure

Nombre 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 sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 12 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Infections transmises par le sangMaladies génito-urinairesMaladies GénitalesInfections bactériennes et mycosesMaladies TransmissiblesSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsMaladies pulmonairesMaladies pulmonaires fongiquesMycosesInfections opportunistesProcessus pathologiquesPneumonieTroubles respiratoiresMaladies des voies respiratoiresInfections des voies respiratoiresInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentConditions pathologiques, signes et symptômesMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à LentivirusInfections à PneumocystisSyndrome d'Immunodéficience AcquisePneumonie à PneumocystisInfections à VIHInfections opportunistes liées au SIDAAspiration Respiratoire

Critères

Inclusion Criteria Patients must fulfill the following criteria: Randomization within 10 weeks of completing therapy for Pneumocystis carinii pneumonia (PCP). Ability to tolerate oral and aerosolized therapy at the time of randomization. Life expectancy > 4 months. Concurrent Medication: Allowed: Inhaled bronchodilators for cough and bronchospasm related to aerosolized pentamidine treatment. Aspirin at modest doses. Ibuprofen at modest doses. Acetaminophen at modest doses. Erythropoietin for management of anemia. Allowed to treat opportunistic infections while on study: Acyclovir. Ketoconazole. Amphotericin B. Nystatin. Clotrimazole. Also allowed: Ganciclovir (DHPG) for maintenance therapy of life-threatening or sight-threatening cytomegalovirus retinitis (CMV retinitis) infection only. Zidovudine (AZT) must be discontinued during the acute induction phase of treatment and will be restarted when maintenance therapy is introduced. Concurrent Treatment: Allowed: Local radiation therapy for Kaposi's sarcoma. Prior Medication: Allowed: Primary prophylactic therapy prior to Pneumocystis carinii pneumonia (PCP) episode. Risk Behavior: Allowed: Patients maintained in a methadone maintenance program per local investigator's judgment. Exclusion Criteria Active drug or alcohol abuse which would impair performance as a study subject. Concurrent Medication: Excluded: Famotidine. Any medications suspected of interference with the metabolism of zidovudine. Flurazepam. Chronic probenecid. Phenobarbital. Phenytoin. Experimental therapies, except as noted. Chronic oral bronchodilators should not be started in patients in order to maintain them on aerosolized pentamidine after they have exhibited pulmonary toxicity. Prior Medication: Excluded for the 30 patients who will undergo pharmacokinetic studies: Zidovudine (AZT) at any time. Excluded within 7 days of study entry for the 30 patients who will undergo pharmacokinetic studies: Trimethoprim / sulfamethoxazole. Pyrimethamine / sulfadoxine. Aerosolized pentamidine. Excluded: Pentamidine by any route for the original infection. Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) between the discontinuation of acute treatment and study entry. Prior Treatment: Excluded within 2 weeks of study entry: Transfusions of blood or red blood cells. Patients may not have any of the following symptoms or diseases: Known treatment-limiting hypersensitivity to sulfonamides, trimethoprim, pyrimethamine, pentamidine, or zidovudine (AZT), especially but not limited to, exfoliative dermatitis, erythema multiforme, and Stevens-Johnson syndrome. Development of severe hypoglycemia (serum glucose < 50 mg/dl with pentamidine therapy). History of neoplasms other than basal cell carcinoma of the skin or carcinoma in situ of the cervix, or mucocutaneous Kaposi's sarcoma. Known visceral Kaposi's sarcoma. Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

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 9 sites

USC CRS

Los Angeles, United StatesOuvrir USC CRS dans Google Maps

Ucsd, Avrc Crs

San Diego, United States

Ucsf Aids Crs

San Francisco, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, United States
Terminé9 Centres d'Étude