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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 f...

Gender

ALL

Eligibility 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.

Trial Officials