Terminated

Phase Not Applicable
Age: 18Years +
All Genders
ID00001128

A Pilot, Proof-of-Concept, Dose-Escalating Trial of Recombinant Human Interleukin-12 (rhIL-12) Versus Placebo Along With Paromomycin and Azithromycin for Chronic Cryptosporidiosis in AIDS

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2016-12-14

16

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

G

Genetics Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Treatment of Chronic Cryptosporidiosis in AIDS Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

Pablo C. Okhuysen

Houston, Texas, United States, 77030

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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