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

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sulfamethoxazole-Trimethoprim
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Sulfamethoxazole-Trimethoprim

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC CRS
  • Stanford CRS
  • Ucsf Aids Crs
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • Harbor-UCLA Med. Ctr. CRS
  • University of Colorado Hospital CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami AIDS CRS
  • Queens Med. Ctr.
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Cook County Hosp. CORE Ctr.
  • Rush Univ. Med. Ctr. ACTG CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Methodist Hosp. of Indiana
  • Tulane/LSU Maternal/Child CRS
  • Johns Hopkins Adult AIDS CRS
  • Massachusetts General Hospital ACTG CRS
  • Bmc Actg Crs
  • Beth Israel Deaconess - East Campus A0102 CRS
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
  • Hennepin County Med. Ctr., Div. of Infectious Diseases
  • University of Minnesota, ACTU
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
  • SUNY - Buffalo, Erie County Medical Ctr.
  • NY Univ. HIV/AIDS CRS
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • Univ. of Rochester ACTG CRS
  • Unc Aids Crs
  • Carolinas HealthCare System, Carolinas Med. Ctr.
  • Regional Center for Infectious Disease, Wendover Medical Center CRS
  • Univ. of Cincinnati CRS
  • MetroHealth CRS
  • Case CRS
  • The Ohio State Univ. AIDS CRS
  • Hosp. of the Univ. of Pennsylvania CRS
  • University of Washington AIDS CRS
  • San Juan City Hosp. PR NICHD CRS
  • Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000816
Brief Title
Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
Official Title
Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome

4. Oversight

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Sulfamethoxazole-Trimethoprim

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
370 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole-Trimethoprim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Para MF
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dohn MN
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Frame P
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
Country
United States
Facility Name
Harbor-UCLA Med. Ctr. CRS
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Queens Med. Ctr.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cook County Hosp. CORE Ctr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess - East Campus A0102 CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Deaconess Med. Ctr., ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hennepin County Med. Ctr., Div. of Infectious Diseases
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Minnesota, ACTU
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas HealthCare System, Carolinas Med. Ctr.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Regional Center for Infectious Disease, Wendover Medical Center CRS
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
MetroHealth CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
City
Mbeya
Country
Tanzania

12. IPD Sharing Statement

Citations:
Citation
Para MF, Dohn M, Frame P, Becker S, Finkelstein D, Walawander A. ACTG 268 trial - gradual initiation of trimethoprim/sulfamethoxazole (T/S) as primary prophylaxis for Pneumocystis carinii pneumonia (PCP). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:65 (abstract no 2)
Results Reference
background
PubMed Identifier
11015150
Citation
Para MF, Finkelstein D, Becker S, Dohn M, Walawander A, Black JR. Reduced toxicity with gradual initiation of trimethoprim-sulfamethoxazole as primary prophylaxis for Pneumocystis carinii pneumonia: AIDS Clinical Trials Group 268. J Acquir Immune Defic Syndr. 2000 Aug 1;24(4):337-43. doi: 10.1097/00126334-200008010-00007.
Results Reference
background

Learn more about this trial

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

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