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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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
September 1996
Not Provided

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico,   Tanzania
 
NCT00000816
ACTG 268, 11244
Not Provided
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