Study on Interleukin-7 (CYT107) in HIV Patients

NCT01190111 | Terminated Phase 2 DMC

• 1 other identifier: CLI-107-13
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

HIV

Keywords

interleukin-7; immune-based therapy; HIV; viral disease

Outcome Measures

Primary Outcomes (1)

• • 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.

  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. • • •

  2 years

Other Outcomes (1)

• clinical and lab assessment Imaging, EKG and Ultrasound IL-7 Pharmacokinetics and Immunogenicity IL-7 Pharmacodynamics/Immunology Bacterial Translocation and HLA typing

  every 3 months up to the end of study period 2years

Study Arms (1)

CYT107 (r-hIL-7)

EXPERIMENTAL

Biological: Interleukin-7

Interventions

Interleukin-7 BIOLOGICAL

20 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response

Also known as: CYT107

CYT107 (r-hIL-7)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Cytheris SA: lead

Study Sites (4)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Niaid/Nih

Bethesda, Maryland, 20892, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

McGill University Health Center (MUHC)

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (1)

• 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.

  PMID: 26908786 DERIVED

MeSH Terms

Conditions

Virus Diseases

Interventions

Interleukin-7

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Michael M. Lederman,, Pr

  Case Western Reserve University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 27, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

US (3); CA (1)