Efficacy of subcutaneous interleukin-2 (IL-2) in the treament of advanced HIV-1 infections in persons with CD4+ T lymphoytes <100/mm3 and undetectable plasma viral load

ISRCTN	ISRCTN34382898
DOI	https://doi.org/10.1186/ISRCTN34382898
Protocol serial number	N0155102865
Sponsor	Department of Health (UK)
Funder	North Manchester Healthcare NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr A Bonington
Scientific

Infectious Diseases
Delaunays Arch
North Manchester General Hospital
Delaunays Rd, Crumpsall
Manchester
M8 5RB
United Kingdom

Phone	+44 0161-720-2729
Email	alec.bonington@pat.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Will IL-2 increase CD4+ counts in HIV -1 infected patients with advanced disease but undetectable viral load on HAART?
Ethics approval(s)	Added June 2008: North Manchester Research Ethics Committee, ref NOR/00/103, 11/04/2001.
Health condition(s) or problem(s) studied	Infections and Infestations: Human immunodeficiency virus (HIV)
Intervention	30 patients randomised to highly active antiretroviral therapy (HAART) + IL-2 or HAART alone after 16 weeks, all patients -> IL-2 10/09/2012: Please note that this trial was stopped in 2009 due to a lack of participants
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	interleukin-2 (IL-2)
Primary outcome measure(s)	Rise in CD4 count by >50% above baseline.
Key secondary outcome measure(s)	Proportion of subjects with final HIV RNA <400 copies/ml.
Completion date	31/05/2009
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	30
Key inclusion criteria	Added June 2008: 1. Age equal to or greater than18 yrs old 2. HIV seropositive 3. On HAART (3 or more antiretroviral drugs) 4. HIV viral load < 400 copies/ml for ≥ 3 months 5. CD4 count ≤ 100 cells/mm3 despite points 3. & 4. above
Key exclusion criteria	Added June 2008: 1. Active infection under investigation or treatment 2. Predicted poor compliance or poor attender 3. Pregnancy or breast-feeding 4. On-going treatment with interferon 5. Previous adverse reaction to IL-2 6. Clinically significant cardiac, pulmonary thyroid or neurologic impairment 7. Malignancy requiring systemic chemotherapy 8. Hb<9.5 g/dl, platelet count < 75,000/mm3, absolute neutrophil count < 1000 cells/mm3, serum creatinine> 2 times upper limit of normal (ULN), ALT >5 times ULN, bilirubin >2 times ULN (protease-induced hyperbilirubinaemia > 5 times ULN), amylase >2 times ULN
Date of first enrolment	17/04/2001
Date of final enrolment	31/05/2009

Infectious Diseases

Manchester
M8 5RB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes