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

This study has been completed.
Sponsor:
Collaborator:
Glaxo Wellcome
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000816
First received: November 2, 1999
Last updated: April 13, 2012
Last verified: April 2012
November 2, 1999
April 13, 2012
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Complete list of historical versions of study NCT00000816 on ClinicalTrials.gov Archive Site
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Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis

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.

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.

Interventional
Phase 4
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
Drug: Sulfamethoxazole-Trimethoprim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
September 1996
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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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   Tanzania,   United States
 
 
NCT00000816
ACTG 268
11244 ( Registry Identifier: DAIDS ES Registry Number )
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Study Chair: Para MF
Study Chair: Dohn MN
Study Chair: Frame P
National Institute of Allergy and Infectious Diseases (NIAID)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP