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

Completed

• Conditions: Infections and Infestations: Human immunodeficiency virus (HIV); Infections and Infestations; Human immunodeficiency virus (HIV)

• Registration Number: ISRCTN34382898
• Lead Sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rise in CD4 count by >50% above baseline.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with final HIV RNA <400 copies/ml.