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Search / Trial NCT00001128

Treatment of Chronic Cryptosporidiosis in AIDS Patients

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

Trial Information

Current as of May 10, 2025

Terminated

Keywords

Aids Related Opportunistic Infections Cryptosporidiosis Acquired Immunodeficiency Syndrome Azithromycin Paromomycin Interleukin 12

ClinConnect Summary

Cryptosporidium parvum, an intracellular protozoan parasite, is a frequent cause of chronic diarrhea in HIV-infected patients, causing significant morbidity and mortality. Highly effective antiparasitic treatment for this infection is not currently available. Paromomycin and azithromycin have some efficacy and have been used in combination in a small number of patients. Immune reconstitution with highly active antiretroviral therapy appears to be the most effective therapy, but this is not possible for all patients. Interferon gamma expression is strongly associated with control of cryptosp...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Have a CD4 cell count below 150 cells/mm3.
  • Have been on stable anti-HIV therapy that includes at least 2 nucleoside analogues for at least 4 weeks.
  • Have chronic diarrhea (3 bowel movements a day that are loose or watery, for 5 days per week over 3 weeks).
  • Test positively for Cryptosporidium.
  • Are at least 18 years old.
  • Agree to use effective methods of birth control.
  • Exclusion Criteria
  • Patients will not be eligible for this study if they:
  • Have any other active opportunistic (AIDS-related) infection.
  • Require intravenous (IV) fluids.
  • Have a history of an allergy to certain medications, such as colony-stimulating factors (G-CSF or GM-CSF) or a type of antibiotic.
  • Are pregnant.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

A. Clinton White

Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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