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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00099671
First received: December 17, 2004
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Recombinant human interleukin-7
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Safety, as assessed by dose-limiting toxicities

Secondary Outcome Measures:
  • 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

Enrollment: 25
Study Start Date: April 2005
Study Completion Date: April 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099671

Locations
United States, California
Univ. of California Davis Med. Ctr., ACTU
Sacremento, California, United States, 95817
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136-1013
United States, Illinois
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612-3806
United States, Ohio
Case CRS
Cleveland, Ohio, United States, 44106-5083
MetroHealth CRS
Cleveland, Ohio, United States, 44109-1998
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00099671     History of Changes
Other Study ID Numbers: A5214, 10022, ACTG A5214
Study First Received: December 17, 2004
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014