HIVPhase 2Inspire 2NCT01190111
Study on Interleukin-7 (CYT107) in HIV Patients
A Phase 2 study testing Interleukin-7 in people with HIV, run by Cytheris SA at 4 sites in 2 countries.
Trial summary
This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Interleukin-7
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2010to Jun 2013
- Phase
- Phase 2
- 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-1 infection as documented by any licensed ELISA test kit and confirmed by Western Blot at any time prior to study entry.
- Age ≥18.
- On HAART for at least 12 months, on stable regimen for at least 3 months prior to enrollment. HAART is defined as a combination of 2 classes dose regimen of approved ARV.
- CD4 cell counts ≥ 101 and < 400 cells/mm3 on two (2) consecutive measurements (including the screening value) within the previous 12 months prior to enrollment.
- Plasma HIV RNA < 50 copies/mL on at least two consecutive measurements (including the screening value) within the previous 6 months prior to enrollment. Note: Patients with single blip of detectable viremia during this period (6 months prior screening) will be allowed to participate if the prior and subsequent plasma HIV RNA levels are below the limits of detection.
- No AIDS-defining illness (category C) diagnosed within the last 6 months prior to enrollment.
Who cannot join
- Use of any other investigational antiretroviral agents.
- Any planned or probable modification of the anti-retroviral treatment during the first 3 month study period.
- Current or recent history (<30 days prior to screening) of a viral, bacterial, parasitic or fungal infection requiring systemic treatment and/or hospitalization.
- Positive PPD unless there is documentation of completion of INH therapy for latent tuberculosis.
- Any serious illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or is clinically stable on therapy, in the opinion of the principal investigator, for at least 28 days prior to study .
- Any history of malignancy (except basal carcinoma of the skin) including any hematologic malignancy or AIDS defining malignancy, such as lymphoproliferative disorder or Kaposi's sarcoma. (Patients with Kaposi's sarcoma limited to the skin that disappeared while on HAART therapy, and without requiring any other systemic therapy, 1 year prior to study entry will be eligible to participate).
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- Any history of HIV related encephalopathy.
- Hepatitis B or C (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load or positive anti HCV antibodies with a detectable HCV RNA viral load). Patients who became negative to HBV DNA or HCV RNA following an antiviral treatment should not be enrolled.
- HIV-2, HTLV-1 or HTLV-2 seropositivity.
- Pregnant or lactating women. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry.
- Refusal or inability to practice contraception regardless of the gender of the patient.
- Hypertension with a resting systolic blood pressure > 140 or a resting diastolic blood pressure > 90 mm despite adequate antihypertensive treatment.
- Use of tipranavir/ritonavir (TPV/r) and Enfuvirtide (T-20).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Niaid/Nih
Bethesda, Maryland, 20892
Case Western Reserve University
Cleveland, Ohio, 44106
University of Miami School of Medicine
Miami, Florida, 33136
About this study
Official title: An Open-label, Multicenter Study of Subcutaneous Intermittent Recombinant Interleukin-7 (CYT107) in Chronically HIV-infected Patients With CD4 T-lymphocyte Counts Between 101-400 Cells/mm3 and Plasma HIV RNA< 50 Copies/mL After at Least 12 Months of HAART
This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
Read the detailed description
This was a phase IIa study assessing weekly doses of CYT107 in addition to antiviral treatment (HAART) in adult patients with HIV.
CYT107 were administered at the dose of 20 µg/kg based on the patient's weight, in 3 weekly administrations. CYT107 Subcutaneous injection administered at the clinic or day hospital
Patients were followed every 3 months for primary and secondary biological activity criteria as well as safety up to 24 months long term follow-up with quarterly visits.
A cycle = 3 weekly administrations; D/d0; D/d7; D/d14 For all patients there will be a maximum of 3 cycles over 12 months and a maximum of 4 cycles over 21 months, for a total duration on study of 24 months.
All patients were receiving and continued to receive combination antiretroviral therapy while on-study.
Pre-medication was not be used systematically but might be administered if needed according to standard clinical practice.
During the study visits the following may be done:
- Medical history, physical examination, blood tests every visit.
- Electrocardiogram (EKG)
- Chest x-ray study
- Liver/spleen imaging
- Blood sample collections at frequent intervals for laboratory tests (Virology: HIV RNA \&HIV DNA;Pharmacodynamics/Immunology;Bacterial translocation )
- Urine tests several times during the study.
PBMCs collections for immunological testing
An optional substudy on gut biopsy performed prior and at month 3 after the first CYT107 cycle to evaluate T cell homing
- Conditions
- HIV
- Being tested
- Interleukin-7
- Keywords
- interleukin-7, immune-based therapy, HIV, viral disease
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-7Biological
Also called CYT107
20 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response
| Study group | Role | What they receive |
|---|---|---|
| CYT107 (r-hIL-7) | Experimental | Not described Receives: Biological: Interleukin-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To study, in all included patients, the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
Measured: 2 years (24 months)
Secondary outcomes (1)
• To characterize in the first 12 patients, PK and PD of CYT107 . • To further characterize in all included patients, the safety profile established with CYT107 at 20 µg/kg including monitoring of HIV RNA and immunogenicity. • • •
- To characterize in the first 12 patients, PK and PD of CYT107 .
- To further characterize, the safety profile established with CYT107 at 20 µg/kg including monitoring of HIV RNA and immunogenicity.
- To further examine CYT107 effect on HIV specific T-cells.
- To document other properties of IL-7, (ie: T-cell homing within the GI tract).
- To assess the sustained CD4 increase until the end of the two years
- the safety of CYT107 treatment over the same period
- the potential effect of the CYT107 induced immune reconstitution on HIV-induced chronic systemic immune hyper-activation and its consequences
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT 107 were followed up for at the least 3 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytheris SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael M. Lederman,, Pr, Study chair, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190111
- Sponsor's protocol ID
- CLI-107-13
- Acronym
- Inspire 2
- Status last verified
- Jul 2013
- First submitted
- 23 Aug 2010
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thiebaut R, Jarne A, Routy JP, Sereti I, Fischl M, Ive P, Speck RF, D'Offizi G, Casari S, Commenges D, Foulkes S, Natarajan V, Croughs T, Delfraissy JF, Tambussi G, Levy Y, Lederman MM. Repeated Cycles of Recombinant Human Interleukin 7 in HIV-Infected Patients With Low CD4 T-Cell Reconstitution on Antiretroviral Therapy: Results of 2 Phase II Multicenter Studies. Clin Infect Dis. 2016 May 1;62(9):1178-1185. doi: 10.1093/cid/ciw065. Epub 2016 Feb 7.
PubMed 26908786
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study of Subcutaneous Intermittent Recombinant Interleukin-7 (CYT107) in Chronically HIV-infected Patients With CD4 T-lymphocyte Counts Between 101-400 Cells/mm3 and Plasma HIV RNA< 50 Copies/mL After at Least 12 Months of HAART
- ClinicalTrials.gov ID
- NCT01190111
- Acronym / sponsor ID
- Inspire 2 / CLI-107-13
- Conditions
- HIV
- Keywords
- interleukin-7, immune-based therapy, HIV, viral disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT 107 were followed up for at the least 3 months.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cytheris SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Aug 2010 (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.
This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
Detailed description
This was a phase IIa study assessing weekly doses of CYT107 in addition to antiviral treatment (HAART) in adult patients with HIV.
CYT107 were administered at the dose of 20 µg/kg based on the patient's weight, in 3 weekly administrations. CYT107 Subcutaneous injection administered at the clinic or day hospital
Patients were followed every 3 months for primary and secondary biological activity criteria as well as safety up to 24 months long term follow-up with quarterly visits.
A cycle = 3 weekly administrations; D/d0; D/d7; D/d14 For all patients there will be a maximum of 3 cycles over 12 months and a maximum of 4 cycles over 21 months, for a total duration on study of 24 months.
All patients were receiving and continued to receive combination antiretroviral therapy while on-study.
Pre-medication was not be used systematically but might be administered if needed according to standard clinical practice.
During the study visits the following may be done:
- Medical history, physical examination, blood tests every visit.
- Electrocardiogram (EKG)
- Chest x-ray study
- Liver/spleen imaging
- Blood sample collections at frequent intervals for laboratory tests (Virology: HIV RNA \&HIV DNA;Pharmacodynamics/Immunology;Bacterial translocation )
- Urine tests several times during the study.
PBMCs collections for immunological testing
An optional substudy on gut biopsy performed prior and at month 3 after the first CYT107 cycle to evaluate T cell homing
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CYT107 (r-hIL-7) | Experimental | Biological: Interleukin-7 |
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-1 infection as documented by any licensed ELISA test kit and confirmed by Western Blot at any time prior to study entry.
- Age ≥18.
- On HAART for at least 12 months, on stable regimen for at least 3 months prior to enrollment. HAART is defined as a combination of 2 classes dose regimen of approved ARV.
- CD4 cell counts ≥ 101 and < 400 cells/mm3 on two (2) consecutive measurements (including the screening value) within the previous 12 months prior to enrollment.
- Plasma HIV RNA < 50 copies/mL on at least two consecutive measurements (including the screening value) within the previous 6 months prior to enrollment. Note: Patients with single blip of detectable viremia during this period (6 months prior screening) will be allowed to participate if the prior and subsequent plasma HIV RNA levels are below the limits of detection.
Key exclusion criteria (13 listed)
- Use of any other investigational antiretroviral agents.
- Any planned or probable modification of the anti-retroviral treatment during the first 3 month study period.
- Current or recent history (<30 days prior to screening) of a viral, bacterial, parasitic or fungal infection requiring systemic treatment and/or hospitalization.
- Positive PPD unless there is documentation of completion of INH therapy for latent tuberculosis.
- Any serious illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or is clinically stable on therapy, in the opinion of the principal investigator, for at least 28 days prior to study .
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 |
|---|---|---|
| Interleukin-7Also: CYT10720 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response | Biological | CYT107 (r-hIL-7) |
Primary outcome
• To study, in all included patients, the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
Time frame: 2 years (24 months)
1 secondary outcome
• To characterize in the first 12 patients, PK and PD of CYT107 . • To further characterize in all included patients, the safety profile established with CYT107 at 20 µg/kg including monitoring of HIV RNA and immunogenicity. • • •
Time frame: 2 years
Results and safety
The study was stopped early (reason given: CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT 107 were followed up for at the least 3 months.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
- Derived from this study: PubMed 26908786Thiebaut R, Jarne A, Routy JP, Sereti I, Fischl M, Ive P, Speck RF, D'Offizi G, Casari S, Commenges D, Foulkes S, Natarajan V, Croughs T, Delfraissy JF, Tambussi G, Levy Y, Lederman MM. Repeated Cycles of Recombinant Human Interleukin 7 in HIV-Infected Patients With Low CD4 T-Cell Reconstitution on Antiretroviral Therapy: Results of 2 Phase II Multicenter Studies. Clin Infect Dis. 2016 May 1;62(9):1178-1185. doi: 10.1093/cid/ciw065. Epub 2016 Feb 7.
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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.
Michael M. Lederman,, Pr study chair
Case Western Reserve University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interleukin-7 in people with HIV, run by Cytheris SA at 4 sites in 2 countries.
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 13 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: stopped early, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT 107 were followed up for at the least 3 months.). Results are not available in the source record.
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?
• To study, in all included patients, the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months. (time frame: 2 years (24 months)). 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 NCT01190111, which also lists 1 linked publication.
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 Aug 2013.