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| Evaluation of the efficacy of hydroxychloroquine in decreasing immune activation and viral replication in asymptomatic Human Immunodeficiency Virus (HIV)-infected patients |
| Source of record | UK Trials |
| ISRCTN | ISRCTN30019040 |
| Date ISRCTN assigned | 22/10/2007 |
| Local reference number(s) | HCQ-01; 082163/Z/07/Z |
| Public title | Evaluation of the efficacy of hydroxychloroquine in decreasing immune activation and viral replication in asymptomatic Human Immunodeficiency Virus (HIV)-infected patients |
| Scientific title | |
| Acronym | HCQ-01 (HydroxyChloroQuine study) |
| Disease/condition/study domain | Early Human Immunodeficiency Virus (HIV) infection |
| Study hypothesis | The main objective of the study is to determine whether hydroxychloroquine decreases immune activation in HIV, as shown by at least a 25% reduction in CD8 T-cell activation after 48 weeks of treatment. The study also intends to examine the effects of hydroxychloroquine on viral load and CD4 T-cell count at week 48, and to assess safety in this patient population. |
| Design/methodology | This is a phase II, multi-centre, randomised, double-blind, placebo-controlled clinical trial |
| Research ethics review | Pending as of 26/09/2007 - through central allocation system |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male or female patients with documented HIV infection on Enzyme-Linked Immuno-Sorbent Assay (ELISA) and confirmatory test 2. Age 18 to 60 years 3. Naive to antiretroviral therapy 4. CD4 T-cell count greater than 400 cells/µL on screening blood test and on one other test performed within three months prior to screening 5. Plasma viral load greater than 5000 copies/ml on screening blood test 6. Willing and able to provide written informed consent 7. Women of childbearing age must be willing to use contraception during the study and for a period of three months afterwards 8. Written informed consent |
| Participants - exclusion criteria | 1. Use of corticosteroids or other immunomodulatory drugs within the 12 months prior to enrolment 2. History of psoriasis, porphyria, epilepsy, myasthenia gravis, cardiac arrhythmias, Glucose 6-Phosphate Dehydrogenase (G6PD) deficiency 3. Hepatitis B surface Antigen (HBsAg) positive or Hepatitis C antibody positive 4. Retinopathy or visual field changes defected at eye screening 5. Evidence of cardiac conduction defects on screening Electrocardiogram (ECG) 6. Anaemia (haemoglobin less than 10 g/dl), neutropenia (absolute neutrophil count less than 1.0 x 10^9/L or thrombocytopenia (platelet count less than 120 x 10^9/L) at study screening 7. Liver function tests greater than twice upper limit of normal at study screening 8. Serum creatinine greater than 1.5 times upper limit of normal or estimated creatinine clearance (Cockroft-Gault equation) below 60 ml/min at screening 9. Requirement for use of medication with hepatotoxic effects or known interaction with hydroxychloroquine 10. Depression or previous suicidal attempts 11. Pregnancy or planned pregnancy during the study or lactating women 12. Inability to attend or comply with treatment or follow-up scheduling |
| Patient information material | |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 90 |
| Interventions | Patients will receive hydroxychloroquine 400 mg/day or matching placebo to be taken once daily by mouth for 48 weeks with food. |
| Primary outcome measure(s) | Change in CD8 T-cell activation at week 48 compared to baseline in the two study groups (as shown by a percentage of the cells expressing CD38+ and HLA-DR+). |
| Secondary outcome measure(s) | Efficacy outcome measure: 1. Change in HIV Ribonucleic Acid (RNA) and absolute CD4 T-cell count at week 48 compared to baseline (analysis will compare change in hydroxychloroquine and placebo groups) 2. Change in CD4 T-cell activation at week 48 compared to baseline in the two study groups (as shown by a percentage of the cells expressing CD38+ and HLA-DR+) 3. Proliferation of CD4 and CD8 T-cells (as shown by Ki67 expression), assessed at the end of study 4. Quality of life; the Medical Outcomes Study (MOS)-HIV questionnaire will be used and assessed at the end of the study Safety outcome measure: 5. Clinical and laboratory toxicity monitoring, monitored at every visit |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 082163) |
| Sponsor name | Medical Research Council Clinical Trials Unit (MRC CTU) (UK) |
| Sponsor details | 222 Euston Road London United Kingdom NW1 2DA |
| Sponsor telephone | +44 (0)20 7670 4700 |
| Sponsor fax | +44 (0)20 7670 4818 |
| Sponsor email | nick.paton@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ |
| Contact name | Dr Nicholas Paton |
| Contact details | MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| Contact telephone | +44 (0)20 7670 4808 |
| Contact fax | +44 (0)20 7670 4814 |
| Contact email | nick.paton@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN30019040 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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