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Home > "G" Clinical Trials Conditions > Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis carinii Pneumonia Prophylaxis

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



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

For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: 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.
Details: 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. Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 370

Location and Contact Information:

Overall Study Official:
ParaMF,  Study Chair, 

Stanford Univ Med Ctr
Stanford,  California,  943055107
United States
 

Children's Hosp of Los Angeles
Los Angeles,  California,  90027
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

Thomas Jefferson Univ Hosp
Philadelphia,  Pennsylvania,  191075098
United States
 

Mid - Hudson Care Ctr
Albany,  New York,  122083479
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Univ of Southern California / LA County USC Med Ctr
Los Angeles,  California,  900331079
United States
 

North Central Bronx Hosp / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Univ of Nebraska Med Ctr
Omaha,  Nebraska,  681985130
United States
 

Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

Univ of Florida Health Science Ctr / Pediatrics
Jacksonville,  Florida,  32209
United States
 

Bronx Veterans Administration / Mount Sinai Hosp
Bronx,  New York,  10468
United States
 

Boston Med Ctr
Boston,  Massachusetts,  02118
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

Univ of Minnesota
Minneapolis,  Minnesota,  55455
United States
 

Moses H Cone Memorial Hosp
Greensboro,  North Carolina,  27401
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Adirondack Med Ctr at Saranac Lake
Albany,  New York,  122083479
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Montefiore Med Ctr Adolescent AIDS Program
Bronx,  New York,  10467
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Tulane Univ / Charity Hosp of New Orleans
New Orleans,  Louisiana,  701122699
United States
 

Hennepin County Med Clinic
Minneapolis,  Minnesota,  55415
United States
 

Albany Med College / Division of HIV Medicine A158
Albany,  New York,  122083479
United States
 

Rose Med Ctr
Denver,  Colorado,  80262
United States
 

State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore,  Maryland,  212052196
United States
 

Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville,  Tennessee,  37920
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Meharry Med College
Nashville,  Tennessee,  37203
United States
 

Kaiser Permanente Franklin Med Ctr
Denver,  Colorado,  80262
United States
 

Denver Dept of Health and Hosps
Denver,  Colorado,  80262
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

Queens Med Ctr
Honolulu,  Hawaii,  96816
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Beth Israel Deaconess Med Ctr
Boston,  Massachusetts,  02215
United States
 

MetroHealth Med Ctr
Cleveland,  Ohio,  441091998
United States
 

Harbor UCLA Med Ctr
Torrance,  California,  90502
United States
 

Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst,  New York,  11373
United States
 

Summitt Med Ctr / San Francisco Gen Hosp
Oakland,  California,  94609
United States
 

Carolinas Med Ctr
Charlotte,  North Carolina,  28203
United States
 

Beth Israel Deaconess - West Campus
Boston,  Massachusetts,  02215
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham,  Alabama,  35294
United States
 

Montefiore Med Ctr / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

San Mateo AIDS Program / Stanford Univ
Stanford,  California,  943055107
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

San Juan City Hosp
San Juan,  ,  009367344
Puerto Rico
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

St Paul Ramsey Med Ctr
St. Paul,  Minnesota,  55101
United States
 

SUNY / State Univ of New York
Syracuse,  New York,  13210
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 


Additional Information:
Study ID Numbers:
  ACTG 268; 
Study Start Date: 
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000816

Other Pneumonia, Pneumocystis Carinii Studies:
1. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia

2. A Study of WR 6026 in the Treatment of Pneumocystis carinii Pneumonia (PCP) in HIV-Infected Patients

3. The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS

4. Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients

5. A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX

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

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