Treatment of Chronic Cryptosporidiosis in AIDS Patients

NCT00001128 | Terminated

• 1 other identifier: DAIDS R001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone. Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.

Conditions

Cryptosporidiosis; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Cryptosporidiosis; Acquired Immunodeficiency Syndrome; Azithromycin; Paromomycin; Interleukin-12

Interventions

Interleukin-12 DRUG

Paromomycin sulfate DRUG

Azithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Genetics Institute: collaborator

Study Sites (1)

Pablo C. Okhuysen

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cryptosporidiosis; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

Interleukin-12; Paromomycin; Azithromycin

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Aminoglycosides; Glycosides; Carbohydrates; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• A. Clinton White

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 17, 2000
• First Posted: August 31, 2001
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: December 14, 2016

Record last verified: 2003-06

Locations

US (1)