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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34382898

Enrollment

Registered

2003-09-12

Start date

2001-04-17

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections and Infestations: Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus (HIV)

Interventions

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

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
Rise in CD4 count by >50% above baseline.	—

Secondary

Measure	Time frame
Proportion of subjects with final HIV RNA <400 copies/ml.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026