Terminé

A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

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Ce qui est testé

Collecte de données

Qui peut participer

Infections bactériennes et mycoses+7

+ Infections

+ Maladies pulmonaires fongiques

À partir de 13 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 18 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients. Patients are randomized into one of two treatment groups to receive either (1) 566C80 for 21 days, or (2) SMX/TMP for 21 days. Patients will be stratified according to severity of PCP. Group A will be those with an arterial-alveolar (A-a) DO2 < 35 mm Hg. Group B will have an A-a DO2 of 35-45 mm Hg., and will also be required to receive therapy with Corticosteroids. All doses are taken with food. During the 21 days of treatment, patients are examined clinically for adverse effects and have hematology (blood-related) and clinical chemistry studies conducted a minimum of 2 times weekly. More frequent monitoring may be required at the discretion of the investigator. To evaluate the effectiveness of study medication, the clinical status of each patient is evaluated 2 to 3 times per week (e.g., dyspnea score, cough score, chest tightness/pain score, vital signs). Also, on days 7 and 21 of treatment, an arterial blood gas measurement and chest X-ray are performed. Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy. Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy. This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMX/TMP while the other group will receive SMX/TMP and placebo tablets looking like 566C80.

Titre officielA Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients 
NCT00000655
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 18 janvier 2026
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

300 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 13 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 bactériennes et mycosesInfectionsMaladies pulmonaires fongiquesMaladies pulmonairesMycosesPneumonie à PneumocystisPneumonieInfections des voies respiratoiresMaladies des voies respiratoiresInfections à Pneumocystis

Critères

Inclusion Criteria Patient must have the following: * Presumptive diagnosis of AIDS as defined by the CDC. * Untreated Pneumocystis carinii pneumonia (PCP). * Willingness and ability to give informed consent. Prior Medication: Allowed: * Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) including aerosolized pentamidine or sulfamethoxazole/trimethoprim (SMX/TMP) (at a dose no greater than two DS tablets twice daily). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Judged by the investigator to be in impending respiratory failure. * Malabsorption or vomiting that would, in the judgment of investigator, potentially limit the retention and absorption of an oral therapy. * Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult. Concurrent Medication: Excluded: * Corticosteroid treatment (except replacement therapy or patients in Group B). * Ganciclovir. * Zidovudine (AZT). * Investigational agents including antiretroviral agents (didanosine (ddI), dideoxycytidine (ddC), etc.). Drugs likely to have anti-pneumocystis effect such as: * Sulfonamides. * Pentamidine. * Dapsone. * Trimethoprim. * Other DHFR inhibitors. * Primaquine. * Clindamycin. * Sulfonylureas. Patients with the following are excluded: * Judged by the investigator to be in impending respiratory failure. * Prior therapy for this episode of PCP or treatment within 4 weeks of entry for a prior episode of PCP. * Unable to or refuse to discontinue zidovudine, ganciclovir, or other antiretroviral agents during the 21 day treatment period. * Unable to take medication orally or unwilling or unable to take study medication with food. * Significant psychosis or emotional disorder such that, in the investigator's opinion, the patient would not be compliant with the study protocol. * Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency. * Prior history of life-threatening toxicity to SMX/TMP such as severe rash or Stevens-Johnson syndrome. Prior Medication: Excluded: * Prior therapy for this episode of Pneumocystis carinii pneumonia (PCP) or treatment within 4 weeks for a prior episode of PCP. * Blood transfusions.

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 38 sites

Suspendu

Univ of Alabama at Birmingham

Birmingham, United StatesVoir le site
Suspendu

Kaiser Foundation Hosp

Harbor City, United States
Suspendu

USC

Los Angeles, United States
Suspendu

Dr Richard Meyer

Los Angeles, United States
Terminé38 Centres d'Étude