HIV Infections Clinical Trial
Official title:
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
There is no proven effective treatment for chronic diarrhea caused by the parasite Cryptosporidium in advanced AIDS. This trial will test the safety of interleukin-12 (IL-12) as part of a combination therapy for this parasite.
Cryptosporidium parvum can cause chronic diarrhea and biliary disease in people with AIDS,
resulting in 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. However, in
clinical trials of this drug combination, patients remained infected with the parasite
despite improvement of their symptoms.
Improving the immune system with highly active antiretroviral therapy (HAART) has been the
most effective therapy described for cryptosporidiosis (chronic infection with
Cryptosporidium parvum), with over 80% of patients showing improvement. However, immune
reconstitution is not possible in all patients.
Interferon gamma expression is strongly associated with control of cryptosporidiosis. IL-12
stimulates interferon gamma, and IL-12 treatment has been shown to prevent cryptosporidiosis
in mice. This study will evaluate IL-12 in combination with standard therapy for
cryptosporidiosis in patients with AIDS.
This is a dose-escalation study. All patients will be treated with paromomycin and
azithromycin. The initial group will be treated with either 110 ng/kg IL-12 (6 patients) or
placebo injections (2 patients) twice a week for 4 weeks. If the initial dose is ineffective
and the combination of drugs is tolerated, a second group of patients will be randomized to
either 300 ng/kg IL-12 (6 patients) or placebo injections (2 patients) twice a week for 4
weeks. Patients will be evaluated for eradication of the parasite (as measured by
immunofluorescence and intestinal biopsy), decreases in stool frequency, decreases in 24
hour stool volume, stimulation of intestinal Th1 cytokine production, increases in body
weight, improvements in Karnofsky score, and improvements in serum alkaline phosphatase
levels and transaminases (if elevated at baseline).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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