Condition category
Infections and Infestations
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
10/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes