Search / Trial NCT00000640

A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 26, 2024

Completed

Keywords

Trimethoprim Sulfamethoxazole Combination Pneumonia, Pneumocystis Carinii Primaquine Dapsone Drug Therapy, Combination Acquired Immunodeficiency Syndrome Clindamycin Sulfamethoxazole Trimethoprim

Description

The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation. Patients with confirmed PCP are randomized into one of three treatment groups. Group A receives SMX/TMP. Half of group A receives dapsone placebo (placebo is an inactive substance) daily plus trimethoprim placebo; the other half receives clindamycin placebo plus primaquine placebo. Group B is given dapsone plus trimethoprim. Half of group B receives SM...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Erythropoietin.
  • Maintenance treatment with investigational triazoles (e.g., itraconazole).
  • Antiemetics for nausea/vomiting, antihistamines for rash/pruritus, antipyretics for systemic symptoms (fever, headache, etc.) should be used for treatment of symptoms.
  • Nonsteroidal antiinflammatory agents may be used for control of myalgias, headache, etc.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusions.
  • Patients must have the following:
  • Pneumocystis carinii pneumonia.
  • HIV infection.
  • Willing and able to sign informed consent. Patients under 18 years of age may enter with consent of parent or guardian.
  • Prior Medication:
  • Allowed:
  • Up to 24 hours of treatment with sulfamethoxazole/trimethoprim (SMX/TMP), dapsone / trimethoprim, or clindamycin / primaquine, or one dose of pentamidine for this episode of Pneumocystis carinii pneumonia (PCP).
  • Prior PCP prophylaxis.
  • Required:
  • Adjunctive prednisone therapy in patients with (A-a) DO2 of 35 - 45 torr receiving acute anti-PCP treatment.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions and diseases are excluded:
  • Positive screen for glucose-6-phosphate dehydrogenase deficiency.
  • Known NAD methemoglobin reductase deficiency and/or known hemoglobin M abnormality.
  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Ganciclovir.
  • GM-CSF or G-CSF. Rifampin.
  • Rifabutin.
  • Corticosteroids (in patients with baseline (A-a) DO2 < 35 torr). Investigational drugs not specifically allowed.
  • Folinic acid.
  • Patients with the following are excluded:
  • Previous dose-limiting intolerance to sulfones, trimethoprim, clindamycin, or primaquine.
  • Requirement for other medications potentially effective in the treatment of Pneumocystis carinii pneumonia (PCP) (e.g., pyrimethamine and sulfadiazine).
  • Prior enrollment in ACTG 108. Presence of other concurrent pulmonary pathology that would make interpretation of response to antipneumocystis therapy difficult.
  • Inability to take oral therapy.
  • Prior Medication:
  • Excluded:
  • Acute treatment doses of anti-Pneumocystis carinii pneumonia agents within 30 days prior to study entry except as noted above.
  • Systemic steroids above adrenal replacement doses within 7 days prior to study entry (except for patients with (A-a) DO2 of 35 - 45 torr who receive prednisone in conjunction with acute anti-PCP treatment).

Attachments

readout_NCT00000640_2024-05-26.pdf

4.5 MB

NCT00000640_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Palo Alto, California, United States

San Francisco, California, United States

San Jose, California, United States

San Mateo, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Seattle, Washington, United States

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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3 stars
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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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