Completed

Aerosolized Pentamidine vs. Trimethoprim - Sulfamethoxazole for Pneumocystis Carinii Pneumonia in AIDS

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What is being tested

Pentamidine isethionate

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

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

This study focuses on comparing two treatments for Pneumocystis Carinii Pneumonia, a type of pneumonia common in AIDS patients. The two treatments are aerosolized pentamidine and a combination of trimethoprim plus sulfamethoxazole (TMP / PurposeX). The study aims to find out which treatment works better for this condition, helping to improve care for AIDS patients suffering from this type of pneumonia. In this study, participants receive either aerosolized pentamidine or TMP / PurposeX. The TMP / PurposeX treatment is given intravenously for at least 5 days, then switched to oral administration if the patient's health condition allows. The study measures the effectiveness of these treatments, but it does not mention specific methods for evaluating the results.

NCT00002056
Principal SponsorLyphoMed
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

3 inclusion criteria required to participate
Pneumocystis carinii pneumonia (PCP) in an adult who is HIV positive by ELISA, HIV culture, or p24 antigenemia, or is a member of a risk group for HIV infection (homosexual or bisexual men, intravenous drug abusers, recipients of HIV infected blood products, and the sexual partners of the foregoing groups).
The patient must have a resting Alveolar - arterial oxygen (A-a) DO2 less than 30 mmHg on room air at all ACTG sites, except San Francisco General Hospital. Other sites will enter patients up to a resting (A-a) DO2 = or < 55 mmHg on room air.
Zidovudine is allowed as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.
13 exclusion criteria prevent from participating
Dapsone, whether therapeutic or prophylactic, or any of these agents within 6 weeks of study entry.
Fansidar within 6 weeks of study entry.
Eflornithine (DFMO) within 6 weeks of study entry.
Systemic steroids above adrenal replacement doses within 14 days of study entry.
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

LyphoMed Inc

Rosemont, United StatesOpen LyphoMed Inc in Google Maps
CompletedOne Study Center