Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
Completed · Phase 4
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000816
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 370
- Expected to finish
- 1996-09-01
- Last updated by the study team
- 2021-11-04
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- USC CRS — Los Angeles, California, United States
- Stanford CRS — Palo Alto, California, United States
- Ucsf Aids Crs — San Francisco, California, United States
- Santa Clara Valley Med. Ctr. — San Jose, California, United States
- San Mateo County AIDS Program — San Mateo, California, United States
- Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
- University of Colorado Hospital CRS — Aurora, Colorado, United States
- Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
- Univ. of Miami AIDS CRS — Miami, Florida, United States
- Queens Med. Ctr. — Honolulu, Hawaii, United States
- Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
- Northwestern University CRS — Chicago, Illinois, United States
- Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
- Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
- Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
- Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
- Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
- Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
- Bmc Actg Crs — Boston, Massachusetts, United States
- Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
- Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
- Hennepin County Med. Ctr., Div. of Infectious Diseases — Minneapolis, Minnesota, United States
- University of Minnesota, ACTU — Minneapolis, Minnesota, United States
- St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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