Completed
TMTX and Dapsone vs TMP/SMX for Moderately Severe PCP in AIDS Patients
What is being tested
Trimetrexate glucuronate
+ Trimethoprim
+ Sulfamethoxazole
Drug
Who is being recruted
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+20 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorU.S. Bioscience
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on comparing two treatment options for individuals living with AIDS who are experiencing moderately severe Pneumocystis Carinii pneumonia (PCP), a type of lung infection. The two treatments being studied are a combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection, and trimethoprim/sulfamethoxazole (TMP/SMX). The main goal is to evaluate the safety of these treatments and understand how they might improve care for those affected by this condition.
Principal SponsorU.S. Bioscience
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsPneumocystis InfectionsAcquired Immunodeficiency SyndromePneumonia, PneumocystisHIV Infections
Criteria
4 inclusion criteria required to participate
AIDS
Alveolar-arterial differences in dissolved oxygen >= 35 mm Hg but < 55 mm Hg on room air
Confirmed diagnosis of PCP
Empiric therapy for other opportunistic pulmonary infection (TB or fungi) for the first 72 hours of study enrollment ONLY, until presence of suspected pathogens can be confidently excluded
16 exclusion criteria prevent from participating
AZT, ddI, ddC, d4T, or other antiretroviral therapy
Active opportunistic infections or malignancies requiring induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy)
Active pulmonary tuberculosis or other inadequately treated opportunistic pulmonary infection (e.g., Cryptococcus neoforms, CMV). NOTE: Identification of Mycobacterium avium or CMV in sputum or BAL fluid does not exclude, since these organisms may be present without causing disease
Concurrent pneumothorax
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, United StatesOpen Los Angeles County / Health Research Assoc / Drew Med Ctr in Google MapsCompletedOne Study Center