Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS) Infections and Infestations Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS)
Conditions
Interventions
An open, randomised, three arm, controlled trial to study interruption of antiretroviral therapy with or without IL-2 therapy, in individuals with HIV-1 infection and nadir CD4 cell counts greater tha
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV seropositive 2. Adult (18 years or older) HIV-infected therapy naïve patients 3. On Highly Active Anti-retroviral Therapy (HAART) (more than or equal to three ARTs of any of the three main classes) with viral load less than 50 copies/mL for 12 weeks or more 4. CD4 count nadir more than 50/mm^3 5. CD4 lymphocyte count more than or equal to 300/mm^3 6. Signed informed consent obtained
Exclusion criteria
Exclusion criteria: 1. Patients on hydroxyurea or interferons or any immunomodulating agent besides IL-2 2. Age less than 16 3. Prior IL-2 therapy 4. Use of any approved or experimental antiretroviral drug within four months prior to study therapy 5. Concurrent malignancy other than mucocutaneos Kaposi sarcoma or malignancy treated within the past five years 6. Any concurrent or history of AIDS defining illness 7. Use of systemic corticosteroids, chemotherapy or experimental cytotoxic drugs within four weeks prior to study therapy 8. Use of any agent approved or experimental with clinically significant immunomodulatory effects 9. Any Central Nervous System (CNS) abnormality that requires treatment with anti-seizure medication 10. Patients with current or historical Crohn's disease, psoriasis or other autoimmune/inflammatory diseases with potential life threatening complications 11. Pregnant or lactating women 12. Use of recreational drugs/alcohol that in the opinion of the investigator would affect patient safety and/or compliance 13. Patients with any serious psychiatric, medical and/or cognitive disturbance or illness that in the opinion of the investigator may affect safety, compliance or ability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CD4 decline to les than 100 or new AIDS disease after death 2. Virological failure of therapy at two years after baseline 3. Virological failure of therapy at any time during the two year period after randomisation 4. Changes in levels of total cholesterol 5. Changes in severity of lipodystrophy/ quality of life 6. Incidence of grade three or four adverse | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed