CompletedPhase 3

A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

United States2,500 participants

Plain-language summary

To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients. Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.

Who can participate

Age range13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Patients must have: * HIV infection. * CD4 count \<= 200 cells/mm3 OR a history of prior PCP. * No active pneumocystosis. Patients or their guardians must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Known treatment-limiting reaction to sulfonamides or trimethoprim. Concurrent Medication: Excluded: * Other PCP prophylaxis or medication with anti-PCP activity.

Trial details

NCT IDNCT00000748

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

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