HIVPhase 2Inspire 3NCT01241643
Randomized Study on Multiple Cycles of Interleukin-7 in HIV Patients Immune Non-responders
A Phase 2 study testing CYT107 in people with HIV, run by Cytheris SA at 3 sites in 3 countries.
Trial summary
This is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly doses of Interleukin-7 (CYT107) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- CYT107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 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 (Enzyme-Linked Immunosorbent Assay) test kit and confirmed either by Western Blot or a 2nd test using a different method at any time prior to study entry
- Age ≥18
- On HAART (Highly active anti-retroviral therapy) for at least 24 months, on stable regimen for at least 6 months prior to study entry. HAART is defined as a combination of two (2) classes dose regimen of approved ARV (antiretroviral)
- CD4+ cell counts ≥ 101 and < 350 cells/µL measured on at least two (2) measurements (including the screening value) within the previous 12 months prior to study entry Note: a single isolated value of CD4+ ≥ 350 during this period (12 months prior to study entry) will be allowed to participate if the previous and subsequent CD4+ count is in the range of ≥ 101 and < 350 cells/µL
- Plasma HIV RNA < 50 copies/mL since at least 18 months with at least two (2) measurements (including the screening value) within the previous 6 months prior study entry Note: patients with single blip of detectable viremia during this period (6 months prior to study entry) will be allowed to participate if the prior and subsequent plasma HIV RNA levels are < 50 copies/mL
- Adequate bone marrow, hepatic and renal function as follows:
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- Hemoglobin ≥ 10 g/dl
- Neutrophils ≥ 1,000/µL
- Platelets ≥ 100,000/µL
- AST, ALT, or Alk. Phosph. ≤ 2.5 x ULN
- Total Bilirubin ≤ 1.5 x ULN (or ≤ 5 x ULN if the patient is treated by atazanavir or by indinavir, and if the increase is due to unconjugated bilirubin and if ALT and AST are normal)
- Lipase ≤ 2 x ULN
- PT/PTT ≤ 1.5 x ULN
- Estimated glomerular filtration ≥ 60 ml/min (according to MDRD formula)
- Normal blood Thyroid-Stimulating Hormone (TSH)
- Ability to understand and sign informed consent
Who cannot join
- AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
- History of HIV related encephalopathy
- Active opportunistic infection including active tuberculosis
- Previous treatment with IL-2 or IL-7 at any time prior to study entry
- Any planned or probable modification of the anti-retroviral treatment during the first year or the first two cycles of CYT107 Note: in case of product shortage and in absence of viral mutation suspicion or viral blip, a modification of ARV will not be an exclusion criterion
- Poor compliance on HAART or any other chronic treatment that in the opinion of the investigator will interfere with protocol participation
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- Previous treatment with immuno-modulatory agents such as, systemic corticosteroids, growth factors, immunosuppressive drugs, HIV vaccine, or anti-cancer treatment or hydroxyurea within 3 months prior to study entry
- 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 Note: Patients with Kaposi's sarcoma limited to the skin that had disappeared while on HAART therapy, and without requiring any other systemic therapy 1 year prior to study entry, will be eligible.
- Any history of severe auto-immune disease requiring systemic treatment or hospitalization, or any active auto-immune disease requiring treatment (including multiple sclerosis)
- History of splenectomy
- Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia
- Chronic hepatitis B or C
- HIV-2, HTLV-1 or HTLV-2 seropositivity
- Cirrhosis of any origin, and alcoholic or non alcoholic steato-hepatitis, either proven histologically or suspected
- Hypertension with a resting systolic blood pressure > 140 or a resting diastolic blood pressure > 90 mm despite adequate antihypertensive treatment
- Any cardiac, pulmonary, thyroid, renal, hepatic, gastrointestinal, neurological (central or peripheral) disease requiring therapy and considered as significant by the investigator or a severe disorder of hemostasis
- 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 30 days prior to study entry
- Pregnant or lactating women. Women of childbearing potential must have a negative serum or urine pregnancy test at study entry
- Refusal or inability to practice contraception regardless of the gender of the patient
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
South Africa1 site
Helen Joseph Hospital-Themba Lethu Clinic
Johannesburg, 2092
About this study
Official title: A Multicenter, Open-labeled, Controlled, Randomized Study of Recombinant Interleukin-7 (CYT107) Treatment to Restore and Maintain CD4 T-lymphocyte Counts Above 500 Cells/µL in HIV-infected Patients With CD4 Counts Remaining Between 101-350 Cells/µL After at Least 2 Years of HAART and Plasma HIV RNA < 50 Copies/mL for 18 Months.
This is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly doses of Interleukin-7 (CYT107)
Read the detailed description
The aim of the study is to assess repeated cycles of 3 weekly injections of CYT107 in patients immune non-responders infected with HIV.
Eighty patients will be recruited to study the biological activity and safety of repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months. The entire study will cover a period of 24 months.
During the study visits the following may be done:
- medical history, physical examination, blood test every visit
- EKG
- chest X-Ray
- liver/spleen ultrasound
- Conditions
- HIV
- Being tested
- CYT107
- Keywords
- interleukin-7, immune-based therapies, HIV, infectious disease, immune non-responders
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT107Drug
repeated cycles of 3 injections of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months
| Study group | Role | What they receive |
|---|---|---|
| CYT107 | Experimental | repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months Receives: Drug: CYT107 |
| Control | No intervention | Control arm with possible CYT107 injection after 12 months of study participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the biological activity and safety of repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
Measured: 24 months
Secondary outcomes (3)
To characterize CYT107 Pharmacokinetics (PK) / Pharmacodynamics (PD)
Measured: 24 months
To characterize the key immuno-pharmacological effects
Measured: 24 months
To assess CYT107 effect on HIV-induced chronic systemic immune hyper-activation and its consequences
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Terminated \[CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT107 were followed up for at the least 3 months.\]
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytheris SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241643
- Sponsor's protocol ID
- CLI-107-14
- Acronym
- Inspire 3
- Status last verified
- Jul 2013
- First submitted
- 15 Nov 2010
- Last updated
- 25 Jul 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 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-labeled, Controlled, Randomized Study of Recombinant Interleukin-7 (CYT107) Treatment to Restore and Maintain CD4 T-lymphocyte Counts Above 500 Cells/µL in HIV-infected Patients With CD4 Counts Remaining Between 101-350 Cells/µL After at Least 2 Years of HAART and Plasma HIV RNA < 50 Copies/mL for 18 Months.
- ClinicalTrials.gov ID
- NCT01241643
- Acronym / sponsor ID
- Inspire 3 / CLI-107-14
- Conditions
- HIV
- Keywords
- interleukin-7, immune-based therapies, HIV, infectious disease, immune non-responders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated \[CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT107 were followed up for at the least 3 months.\]
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cytheris SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Nov 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 is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly doses of Interleukin-7 (CYT107)
Detailed description
The aim of the study is to assess repeated cycles of 3 weekly injections of CYT107 in patients immune non-responders infected with HIV.
Eighty patients will be recruited to study the biological activity and safety of repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months. The entire study will cover a period of 24 months.
During the study visits the following may be done:
- medical history, physical examination, blood test every visit
- EKG
- chest X-Ray
- liver/spleen ultrasound
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYT107 | Experimental | Drug: CYT107repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months |
| Control | No intervention | –Control arm with possible CYT107 injection after 12 months of study participation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- HIV-1 infection as documented by any licensed ELISA (Enzyme-Linked Immunosorbent Assay) test kit and confirmed either by Western Blot or a 2nd test using a different method at any time prior to study entry
- Age ≥18
- On HAART (Highly active anti-retroviral therapy) for at least 24 months, on stable regimen for at least 6 months prior to study entry. HAART is defined as a combination of two (2) classes dose regimen of approved ARV (antiretroviral)
- CD4+ cell counts ≥ 101 and < 350 cells/µL measured on at least two (2) measurements (including the screening value) within the previous 12 months prior to study entry Note: a single isolated value of CD4+ ≥ 350 during this period (12 months prior to study entry) will be allowed to participate if the previous and subsequent CD4+ count is in the range of ≥ 101 and < 350 cells/µL
- Plasma HIV RNA < 50 copies/mL since at least 18 months with at least two (2) measurements (including the screening value) within the previous 6 months prior study entry Note: patients with single blip of detectable viremia during this period (6 months prior to study entry) will be allowed to participate if the prior and subsequent plasma HIV RNA levels are < 50 copies/mL
Key exclusion criteria (19 listed)
- AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
- History of HIV related encephalopathy
- Active opportunistic infection including active tuberculosis
- Previous treatment with IL-2 or IL-7 at any time prior to study entry
- Any planned or probable modification of the anti-retroviral treatment during the first year or the first two cycles of CYT107 Note: in case of product shortage and in absence of viral mutation suspicion or viral blip, a modification of ARV will not be an exclusion criterion
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 |
|---|---|---|
| CYT107repeated cycles of 3 injections of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months | Drug | CYT107 |
Primary outcome
To study the biological activity and safety of repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
Time frame: 24 months
3 secondary outcomes
To characterize CYT107 Pharmacokinetics (PK) / Pharmacodynamics (PD)
Time frame: 24 months
To characterize the key immuno-pharmacological effects
Time frame: 24 months
To assess CYT107 effect on HIV-induced chronic systemic immune hyper-activation and its consequences
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Terminated \[CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT107 were followed up for at the least 3 months.\]). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT107 in people with HIV, run by Cytheris SA at 3 sites in 3 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 16 inclusion and 19 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 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, South Africa, Switzerland. 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: Terminated \[CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT107 were followed up for at the least 3 months.\]). 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 the biological activity and safety of repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months. (time frame: 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 NCT01241643, 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 25 Jul 2013.