Daclizumab to Treat HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

This study will examine the safety and effectiveness of daclizumab (also called Zenapax or anti-CD25) in reducing viral replication in patients with HIV infection. Although HAART, an intensive anti-HIV treatment regimen, can suppress HIV in blood below the limit of detection, it cannot completely eradicate the virus. This study will focus on the effectiveness of daclizumab in further reducing viral replication in patients with low viral counts. The Food and Drug Administration approved daclizumab in 1997 for preventing kidney transplant rejection, and it has also been studied in people with an eye infection called uveitis. The drug works by binding to a protein on T cells (white blood cells of the immune system) called CD25. This prevents another protein, called interleukin-2 (IL-2), from binding to this site, thus preventing a series of events that normally results in inflammation. Patients between 18 and 65 years of age with HIV infection who have stable HIV levels at less than 30,000 copies/mL of blood and CD4 T cell counts higher than 400 cells/cmm may be eligible for this study. Patients who have taken drugs that affect the immune system, such as IL-2 and interferon, in the past 5 years may not participate. Candidates are screened with a comprehensive medical examination, including physical examination and laboratory studies. X-rays, consultations, and biopsies are done only if medically indicated. Participants will undergo the following tests and procedures: * Daclizumab therapy: Patients receive daclizumab as a 25-minute infusion through an intravenous catheter (plastic tube placed in a vein) at the NIH Clinical Center outpatient clinic. A total of three doses of drug are given. The first dose is given on study day 1, the second dose is given 2 weeks later, and the third dose is given 4 weeks later. Patients are observed for at least 1 hour after each infusion before being discharged from the clinic. * Follow-up visits: Patients return to the outpatient clinic every 2 weeks while they are on medication and then every month until 3 months after the final dose to evaluate their infection status, response to therapy, and medication side effects. The visits include a physical examination, blood draws, and possibly x-rays, if medically indicated. * Apheresis: Patients undergo apheresis, a procedure for collecting large amounts of white blood cells, three times during the study - once before starting daclizumab therapy, 4 weeks after beginning therapy, and 12 weeks after beginning therapy. For apheresis, blood is removed through a needle in the vein of one arm and spun in a machine that separates it into its components. The white blood cells and plasma are removed, and the red cells and platelets are re-infused either through the same needle or through a needle in a vein in the other arm.

Key facts

Study ID: NCT00080431
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 10
Starts: 2004-03-26
Expected to finish: 2007-12-28
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients who are pregnant or who are nursing infants will not be eligible. Women of child-bearing potential must have a negative pregnancy test on the day of study entry.
Acute or chronic liver disease, history of alcohol abuse or drug abuse that would interfere with participation in the clinical trial.
History of any malignant neoplasm except in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for at least 5 years.
History of bladder cancer.
Previous treatment with daclizumab.
Inability to comply with study guidelines.
Hemocytopenia: platelet count less than 80,000/mm(3), absolute neutrophil count less than 1500/mm(3), hematocrit less than 30% (in the absence of gastrointestinal bleeding or hemolytic anemia).
ALT/AST greater than 5 times the upper limit of normal, PT INR greater than 2 times the upper limit of normal, creatinine greater than 1.5 times the upper limit of normal.
Concurrent use of any other immunosuppressive therapy including systemic steroids for a duration of six weeks or more six months prior to enrollment.
History of use of the immunomodulatory agent such as IL-2 or interferon within the last 5 years.
Known allergy to murine proteins.
Medical illness that in the opinion of the investigator might confound results or interfere with the subject's ability to participate in the trial.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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