Evaluation of the efficacy of hydroxychloroquine in decreasing immune activation and viral replication in asymptomatic human immunodeficiency virus (HIV)-infected patients: a phase II, multicentre, randomised, double-blind, placebo-controlled clinical trial

Medical Research Council Clinical Trials Unit (MRC CTU) (UK)0 sites90 target enrollmentOctober 22, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical Research Council Clinical Trials Unit (MRC CTU) (UK)
Enrollment: 90
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 22, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Medical Research Council Clinical Trials Unit (MRC CTU) (UK)

Eligibility Criteria

Inclusion Criteria

•Current information as of 11/02/2009 (amended in protocol and approved by ethics on 13/10/2008\):
•1\. Documented HIV infection on Enzyme\-Linked Immuno\-Sorbent Assay (ELISA) and confirmatory test
•2\. Age 18 to 65 years, either sex
•3\. Naïve to antiretroviral therapy (ART) or off ART for at least 12 months prior to study entry
•4\. CD4 T\-cell count greater than 400 cells/µL on screening blood test and on one other test performed within the 3 months prior to screening
•5\. Plasma HIV RNA viral load greater than 5000 copies/ml on screening blood test
•6\. Willing and able to provide written informed consent
•Current information as of 29/04/2008:
•1\. Documented HIV infection on Enzyme\-Linked Immuno\-Sorbent Assay (ELISA) and confirmatory test
•2\. Age 18 to 65 years, either sex

Exclusion Criteria

•Current information as of 11/02/2009 (amended in protocol and approved by ethics on 13/10/2008\):
•1\. History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, glucose 6\-phosphate dehydrogenase (G6PD) deficiency
•2\. Insulin\-dependent or non\-insulin\-dependent diabetes mellitus
•3\. Chronic liver disease of any cause or alcoholism
•4\. Primary HIV infection within 12 months prior to screening, either confirmed (previous negative HIV antibody test within 12 months), or suspected (symptoms strongly suggestive of HIV seroconversion illness within the previous 12 months and patient not known to be HIV antibody positive prior to the illness)
•5\. Pneumonia, meningitis, septicaemia or any other serious infection in the 2 months prior to screening
•6\. Any acute infection with fever and systemic symptoms within the last 24 hours
•7\. Any vaccinations in the 2 months prior to screening
•8\. Active malignancy (patients are eligible if treatment for the malignancy was completed more than 2 years prior to screening and there has been no subsequent clinical evidence of active disease) or any active immune\-mediated or inflammatory disease
•9\. Any known suicide attempts (at any time in the past) or current or past history of depression requiring treatment within the 2 years prior to screening. Patients who have not had depression in the previous 2 years but who have had depression in the past may be included if, in the opinion of the physician, the nature of the past episode of depression and the patient?s current psychological state indicate that the risk of recurrence of depression during the trial is likely to be low. Patients who have received anti\-depressant medication for reasons other than symptomatic depression can be included in the trial.