Contact information
Type
Scientific
Primary contact
Dr A Bonington
ORCID ID
Contact details
Infectious Diseases
Delaunays Arch
North Manchester General Hospital
Delaunays Rd
Crumpsall
Manchester
M8 5RB
United Kingdom
+44 0161-720-2729
alec.bonington@pat.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0155102865
Study information
Scientific title
Acronym
Study hypothesis
Will IL-2 increase CD4+ counts in HIV -1 infected patients with advanced disease but undetectable viral load on HAART?
Ethics approval
Added June 2008: North Manchester Research Ethics Committee, ref NOR/00/103, 11/04/2001.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
interleukin-2 (IL-2)
Primary outcome measures
Rise in CD4 count by >50% above baseline.
Secondary outcome measures
Proportion of subjects with final HIV RNA <400 copies/ml.
Overall trial start date
17/04/2001
Overall trial end date
31/05/2009
Reason abandoned
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30
Participant 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
Recruitment start date
17/04/2001
Recruitment end date
31/05/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Infectious Diseases
Manchester
M8 5RB
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Manchester Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary