Completed

l-Leucovorin and Trimethoprim / Sulfamethoxazole for PCP in AIDS Patients

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What is being tested

Trimethoprim

+ Sulfamethoxazole

+ Leucovorin calcium

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorLederle Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on a treatment for Pneumocystis Carinii Pneumonia (PCP), a type of pneumonia common in patients with Acquired Immunodeficiency Syndrome (AIDS). The study aims to evaluate the effectiveness of a drug called l-leucovorin. This drug is used alongside high doses of trimethoprim / sulfamethoxazole (TMP / SMX), a common treatment for PCP. The goal is to see if l-leucovorin can help reduce the side effects caused by the high doses of TMP / SMX. This research is important as it could lead to a safer and more comfortable treatment experience for AIDS patients suffering from PCP. During the study, participants receive both l-leucovorin and TMP / SMX. The effectiveness of l-leucovorin is measured by observing the reduction in side effects typically associated with high doses of TMP / SMX. The study is designed to ensure that neither the participants nor the researchers know who is receiving the real l-leucovorin or a placebo, a substance that has no therapeutic effect. This is done to ensure the results are not influenced by expectations.

Principal SponsorLederle Laboratories
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.

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 18 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, FungalMycosesOpportunistic InfectionsPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsPneumocystis InfectionsAcquired Immunodeficiency SyndromePneumonia, PneumocystisHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

5 inclusion criteria required to participate
Be receiving = or < 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization

Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or > 15mg/kg/day of the trimethoprim component

Diagnosis of PCP

Fit the CDC definition of AIDS

Show More Criteria

3 exclusion criteria prevent from participating
> 48 hours of trimethoprim / sulfamethoxazole prior to randomization

Cannot take oral medications

Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone

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

San Francisco Gen Hosp

San Francisco, United StatesOpen San Francisco Gen Hosp in Google Maps
CompletedOne Study Center