Search / Trial NCT00000802

A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

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

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Pneumonia, Pneumocystis Carinii Dapsone Antifungal Agents Acquired Immunodeficiency Syndrome Atovaquone

Description

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents. Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication: Strongly recommended:
  • Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count < 100 cells/mm3 and are toxoplasmosis seropositive.
  • Patients must have:
  • Working diagnosis of HIV infection.
  • CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocyte count at any time in the past OR a history of PCP.
  • History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation.
  • NOTE:
  • Pregnant patients are eligible at the clinician's discretion.
  • Prior Medication:
  • Allowed:
  • Prior PCP prophylaxis.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active pneumocystosis.
  • Concurrent Medication:
  • Excluded:
  • PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity.
  • Patients with the following prior conditions are excluded:
  • Known treatment-limiting reaction to dapsone or atovaquone.

Attachments

readout_NCT00000802_2023-11-28.pdf

4.5 MB

NCT00000802_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

Birmingham, Alabama, United States

Los Angeles, California, United States

Palo Alto, California, United States

San Diego, 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

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Buffalo, 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

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

Mbeya, , Tanzania

Chicago, Illinois, United States

Honolulu, Hawaii, 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
41
4 stars
6
3 stars
2
2 stars
0
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

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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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