Completed

Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis

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What is being tested

Sulfamethoxazole-Trimethoprim

Drug
Who is being recruted

Pneumonia, Pneumocystis Carinii

+ HIV Infections
Over 13 Years
How is the trial designed

Treatment Study

Phase 4
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients. Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred. Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred. Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.

Official TitleGradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
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
370 patients to be enrolledTotal 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 sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pneumonia, Pneumocystis Carinii
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Allowed if clinically indicated: * Recombinant erythropoietin (rEPO) and G-CSF. Allowed for symptomatic treatment of mild study drug toxicity: * Antipyretics and analgesics (ibuprofen). * Antihistamines (diphenhydramine HCl). * Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use). * Systemic steroids. Patients must have: * HIV infection. * CD4 count \<= 250 cells/mm3 OR history or presence of thrush. * No history of confirmed or probable pneumocystosis. NOTE: * Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment. * This study is appropriate for prisoner participation. * Coenrollment in ongoing ACTG antiretroviral studies is permitted provided no new study drugs are added to the patient's drug regimen for 4 weeks before or after initiation of SMX/TMP. Prior Medication: Allowed: * Prior aerosolized pentamidine and dapsone for primary PCP prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Known adverse reactions to sulfa, trimethoprim, or SMX/TMP. * Inability to comply with dosing schedule or complete dosing record. Concurrent Medication: Excluded: * Procysteine. * Glutathione. * N-acetylcysteine (NAC). * Antihistamines (unless used for symptomatic treatment of study drug toxicity). * Systemic corticosteroids (unless used for replacement purposes). * Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity). * TMP or sulfa drugs outside of the study. Prior Medication: Excluded at any time: * Prior SMX/TMP as primary PCP prophylaxis. Excluded within 4 weeks prior to study entry: * Initiation of antiretroviral agents. * Initiation of anti-infective agents (including SMX/TMP for another indication). Excluded within 2 weeks prior to study entry: * Antihistamines. * Procysteine. * Glutathione. * N-acetylcysteine (NAC). * Systemic corticosteroids (unless used for replacement purposes). * Leucovorin calcium. * TMP and sulfa drugs separately.



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 42 locations
Suspended
USC CRSLos Angeles, United StatesSee the location
Suspended
Stanford CRSPalo Alto, United States
Suspended
Ucsf Aids CrsSan Francisco, United States
Suspended
Santa Clara Valley Med. Ctr.San Jose, United States

Completed42 Study Centers