Search / Trial NCT00000717

The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia 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 December 10, 2023

Completed

Keywords

Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Primaquine Infusions, Intravenous Drug Evaluation Drug Therapy, Combination Administration, Oral Acquired Immunodeficiency Syndrome Clindamycin

Description

As many as 80 percent of AIDS patients experience at least one episode of PCP and about one-third of these patients have a recurrence of the disease. Drugs currently used for treatment of acute PCP are toxic to the majority of AIDS patients. The combination of clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been used safely in humans for treatment of other diseases. It is possible that the combination may prove to be as good or better than standard therapy for PCP ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Oral antiemetics.
  • Patients must have the following for inclusion:
  • HIV positive by ELISA, p24 antigen or culture.
  • Pneumocystis carinii pneumonia (PCP).
  • Patients must have an (A-a) DO2 < 40 mmHg on room air.
  • Willingness to sign an informed consent.
  • Prior Medication:
  • Allowed:
  • - Prophylaxis for Pneumocystis carinii pneumonia (PCP) with agents other than clindamycin and primaquine.
  • Exclusion Criteria
  • Concurrent Medication:
  • Excluded:
  • Hematotoxic therapy, including zidovudine (AZT) or ganciclovir.
  • Patients with the following are excluded:
  • History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs.
  • Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality.
  • Concomitant conditions defined in Patient Exclusion Co-Existing Conditions.
  • Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study.
  • Note:
  • Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.
  • Prior Medication:
  • Excluded within 14 days of study entry:
  • Systemic steroids at doses exceeding physiologic replacement or other investigational agents.
  • Excluded within 6 weeks of study entry:
  • Prior institution of any antiprotozoal therapy for the current episode of Pneumocystis carinii pneumonia or prophylaxis.
  • Patients must not have any of the following symptoms or diseases:
  • History of allergy to clindamycin, lincomycin, or related drugs; or to primaquine or related drugs.
  • Positive screen for G6PD deficiency, known NAD methemoglobin reductase deficiency, and/or known hemoglobin M abnormality.
  • Diarrhea, defined as = or > 3 watery stools per day.
  • Severe nausea and vomiting or other medical condition, such as ileus, that precludes oral therapy.
  • Ventilator dependence or (A-a) DO2 = > 30 mm Hg.
  • Any medical or social situation which, in the opinion of the investigator, would adversely affect participation in the study.
  • Note:
  • Patients may be enrolled while G6PD screen is pending, but must be withdrawn if results are not known within 5 days after entry.

Attachments

readout_NCT00000717_2023-12-10.pdf

4.5 MB

NCT00000717_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

Indianapolis, Indiana, United States

Columbus, Ohio, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

San Francisco, California, United States

Cleveland, Ohio, 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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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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