Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety of a single, under-the-skin dose of interleukin-7 (IL-7) in HIV infected people currently taking anti-HIV drugs.

Key facts

Study ID

NCT00099671

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

25

Starts

2005-04-01

Expected to finish

2007-04-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infected
• Currently on ART consisting of at least 3 antiretroviral drugs for at least 12 months prior to study entry and stable (no change in dose) on treatment for at least 3 months prior to study entry
• CD4 count of 100 cells/mm3 or more within 42 days of study entry
• Viral load of 50,000 copies/ml or less within 42 days of study entry
• Willing to use acceptable forms of contraception
• Participants with a Category C AIDS-defining illness during the 12 months prior to study entry may be eligible as long as their CD4 count is 200 cells/mm3 or more at screening. Participants with Kaposi's sarcoma may also be eligible for this study.

You may not qualify if…

• Lymphadenopathy greater than 2.0 cm
• Known allergy or sensitivity to study drug or its formulations
• Current drug or alcohol abuse
• Serious illness or hospitalization that, in the opinion of the site investigator, may interfere with the study results
• Prior use of any interleukins
• Systemic cancer chemotherapy, systemic investigational agents, or immunomodulators (e.g., growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interferons) within 90 days prior to study entry
• Heparin within 96 hours prior to study entry, or anticipating the need for heparin within 96 hours after the study injection
• History of cancer (except basal carcinoma of the skin or Kaposi's sarcoma)
• Enlargement of spleen
• History of hypercoagulability (deep vein thrombosis or pulmonary embolism)
• History of seizure disorder
• History of extensive psoriasis, Crohn's disease, uveitis, or other autoimmune disease having induced severe complications
• Significant psychiatric, cardiac, pulmonary, thyroid, renal, or neurological disease requiring therapy
• Positive hepatitis B surface antigen or positive hepatitis C antibody at screening
• Plan to start new ART within 8 weeks after study entry
• Breastfeeding

Where it is running

• Univ. of California Davis Med. Ctr., ACTU — Sacramento, California, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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