Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced
Eligibility 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
Sites / Locations
- Univ. of California Davis Med. Ctr., ACTU
- Univ. of Miami AIDS CRS
- Rush Univ. Med. Ctr. ACTG CRS
- Case CRS
- MetroHealth CRS