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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00099671
Recruitment Status : Completed
First Posted : December 20, 2004
Last Update Posted : July 31, 2013
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

December 17, 2004
December 20, 2004
July 31, 2013
April 2005
Not Provided
Safety, as assessed by dose-limiting toxicities
Dose-limiting toxicity
Complete list of historical versions of study NCT00099671 on Archive Site
  • Change in IL-7 plasma level from study entry to Day 28
  • concentrations of recombinant human IL-7 (rhIL-7) at study entry (prior to dose) and at 0.5, 1.0, 1.5, 2.0, 2.5, 4, 8, 12, 24, 48, and 72 hours after dose
  • T-cell proliferation and activation status
  • lymphocyte subsets prior to study entry, study entry and on Days 1, 2, 4, 14, and 28
  • anti-IL-7 antibodies prior to study entry and on Days 28 and 56
  • HIV-1 viral load at baseline and on Days 1, 4, 14, and 28
  • nine-color advanced flow cytometry on stored peripheral blood mononuclear cells (PBMCs) at baseline and on Days 4 and 28
  • effect of age on laboratory outcomes
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Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs
A Phase I, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety of Subcutaneous Single Dose Interleukin-7 in HIV-1-Infected Subjects Who Are Receiving Antiretroviral Treatment
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.

CD4 count is the best predictor of HIV disease progression. IL-7 plays an important role in immune system function, especially in the development of T cells, including CD4 cells. IL-7 may improve HIV-specific immune responses by increasing the number of CD4 cells and boosting immune response. This study will evaluate the safety of a single IL-7 dose given under the skin in HIV infected patients who are currently on potent antiretroviral therapy (ART).

This study will last 13 weeks. Participants will be stratified into two groups by viral load: Stratum 1 participants will have viral loads of less than 50 copies/ml, and Stratum 2 participants will have viral loads between 50 and 50,000 copies/ml. Participants will receive one dose of either IL-7 or placebo at study entry. Five different dosing levels of IL-7 will be tested sequentially in both strata. Dose escalation will occur independently in each stratum and enrollment in a stratum will end when the maximum-tolerated dose is reached. As of 10/23/06, due to adverse events associated with the 60 mcg/kg dose level, all participants will receive up to the 30 mcg/kg dose level, with no further dose escalation. New participants will enroll in Stratum 2 only.

There will be 9 study visits; medical and medication history, a physical exam, lymph node and spleen assessment, and blood collection will occur at most visits. Participants will undergo an electrocardiogram at study entry and on Day 1, and a spleen ultrasound at Week 3. Urine collection will occur on Day 4 and at Weeks 2 and 3.

Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Recombinant human interleukin-7
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2007
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
10022 ( Registry Identifier: DAIDS ES Registry Number )
ACTG A5214
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Irini Sereti, MD National Institute for Allergy and Infectious Diseases, National Institutes of Health
Study Chair: Michael M. Lederman, MD Case Western Reserve University, University Hospitals of Cleveland
National Institute of Allergy and Infectious Diseases (NIAID)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP