Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Pro… (NCT00000816) | Clinical Trial Compass
CompletedPhase 4
Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
United States370 participants
Plain-language summary
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.
Who can participate
Age range13 Years
SexALL
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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 c…
Trial details
NCT IDNCT00000816
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)