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

• Status: Completed
• Trial end date: 1996-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Glaxo Wellcome
• Treatments: Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

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.