A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
Sulfamethoxazole-Trimethoprim
Blood-Borne Infections+23
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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. Patients receive SMX/TMP orally on a daily or thrice-weekly basis. Patients are clinically evaluated every 4 months. Patients on daily SMX/TMP who develop a drug-related toxicity may be switched to thrice-weekly SMX/TMP. Duration of follow-up is 12 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
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 24 locations
Community Consortium of San Francisco
San Francisco, United StatesOpen Community Consortium of San Francisco in Google MapsStanford Univ School of Medicine
Stanford, United StatesDenver CPCRA / Denver Public Hlth
Denver, United StatesWilmington Hosp / Med Ctr of Delaware
Wilmington, United States