Status:
COMPLETED
Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00099671
Start Date
April 1 2005
End Date
April 1 2007
Last Update
November 1 2021
Active Locations (5)
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1
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States, 95817
2
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136-1013
3
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612-3806
4
Case CRS
Cleveland, Ohio, United States, 44106-5083