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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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