HIV InfectionsPhase 1NCT00099671
Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs
A Phase 1 study testing Recombinant human interleukin-7 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Recombinant human interleukin-7
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2005to Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612-3806
Case CRS
Cleveland, Ohio, 44106-5083
MetroHealth CRS
Cleveland, Ohio, 44109-1998
Univ. of Miami AIDS CRS
Miami, Florida, 33136-1013
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, 95817
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Recombinant human interleukin-7
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human interleukin-7Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as assessed by dose-limiting toxicities
Secondary outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2004 (estimated)
- Study startApr 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Irini Sereti, MD, Study chair, National Institute for Allergy and Infectious Diseases, National Institutes of HealthMichael M. Lederman, MD, Study chair, Case Western Reserve University, University Hospitals of Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099671
- Sponsor's protocol ID
- A5214
- Other IDs
- 10022, ACTG A5214
- Status last verified
- Oct 2021
- First submitted
- 17 Dec 2004
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Fry TJ, Mackall CL. Interleukin-7: master regulator of peripheral T-cell homeostasis? Trends Immunol. 2001 Oct;22(10):564-71. doi: 10.1016/s1471-4906(01)02028-2.
PubMed 11574281Geiselhart LA, Humphries CA, Gregorio TA, Mou S, Subleski J, Komschlies KL. IL-7 administration alters the CD4:CD8 ratio, increases T cell numbers, and increases T cell function in the absence of activation. J Immunol. 2001 Mar 1;166(5):3019-27. doi: 10.4049/jimmunol.166.5.3019.
PubMed 11207251Kedzierska K, Crowe SM. Cytokines and HIV-1: interactions and clinical implications. Antivir Chem Chemother. 2001 May;12(3):133-50. doi: 10.1177/095632020101200301.
PubMed 12959322Pett SL, Kelleher AD. Cytokine therapies in HIV-1 infection: present and future. Expert Rev Anti Infect Ther. 2003 Jun;1(1):83-96. doi: 10.1586/14787210.1.1.83.
PubMed 15482104Sereti I, Dunham RM, Spritzler J, Aga E, Proschan MA, Medvik K, Battaglia CA, Landay AL, Pahwa S, Fischl MA, Asmuth DM, Tenorio AR, Altman JD, Fox L, Moir S, Malaspina A, Morre M, Buffet R, Silvestri G, Lederman MM; ACTG 5214 Study Team. IL-7 administration drives T cell-cycle entry and expansion in HIV-1 infection. Blood. 2009 Jun 18;113(25):6304-14. doi: 10.1182/blood-2008-10-186601. Epub 2009 Apr 20.
PubMed 19380868Vandergeeten C, Fromentin R, DaFonseca S, Lawani MB, Sereti I, Lederman MM, Ramgopal M, Routy JP, Sekaly RP, Chomont N. Interleukin-7 promotes HIV persistence during antiretroviral therapy. Blood. 2013 May 23;121(21):4321-9. doi: 10.1182/blood-2012-11-465625. Epub 2013 Apr 15.
PubMed 23589672
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00099671
- Acronym / sponsor ID
- A5214
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human interleukin-7 | Drug | – |
Primary outcome
Safety, as assessed by dose-limiting toxicities
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 11574281Fry TJ, Mackall CL. Interleukin-7: master regulator of peripheral T-cell homeostasis? Trends Immunol. 2001 Oct;22(10):564-71. doi: 10.1016/s1471-4906(01)02028-2.
- Background: PubMed 11207251Geiselhart LA, Humphries CA, Gregorio TA, Mou S, Subleski J, Komschlies KL. IL-7 administration alters the CD4:CD8 ratio, increases T cell numbers, and increases T cell function in the absence of activation. J Immunol. 2001 Mar 1;166(5):3019-27. doi: 10.4049/jimmunol.166.5.3019.
- Background: PubMed 12959322Kedzierska K, Crowe SM. Cytokines and HIV-1: interactions and clinical implications. Antivir Chem Chemother. 2001 May;12(3):133-50. doi: 10.1177/095632020101200301.
- Background: PubMed 15482104Pett SL, Kelleher AD. Cytokine therapies in HIV-1 infection: present and future. Expert Rev Anti Infect Ther. 2003 Jun;1(1):83-96. doi: 10.1586/14787210.1.1.83.
- Results publication: PubMed 19380868Sereti I, Dunham RM, Spritzler J, Aga E, Proschan MA, Medvik K, Battaglia CA, Landay AL, Pahwa S, Fischl MA, Asmuth DM, Tenorio AR, Altman JD, Fox L, Moir S, Malaspina A, Morre M, Buffet R, Silvestri G, Lederman MM; ACTG 5214 Study Team. IL-7 administration drives T cell-cycle entry and expansion in HIV-1 infection. Blood. 2009 Jun 18;113(25):6304-14. doi: 10.1182/blood-2008-10-186601. Epub 2009 Apr 20.
- Derived from this study: PubMed 23589672Vandergeeten C, Fromentin R, DaFonseca S, Lawani MB, Sereti I, Lederman MM, Ramgopal M, Routy JP, Sekaly RP, Chomont N. Interleukin-7 promotes HIV persistence during antiretroviral therapy. Blood. 2013 May 23;121(21):4321-9. doi: 10.1182/blood-2012-11-465625. Epub 2013 Apr 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irini Sereti, MD study chair
National Institute for Allergy and Infectious Diseases, National Institutes of Health
Michael M. Lederman, MD study chair
Case Western Reserve University, University Hospitals of Cleveland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human interleukin-7 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, as assessed by dose-limiting toxicities. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099671, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.