Evaluation of the efficacy of hydroxychloroquine in decreasing immune activation in asymptomatic HIV-infected patients (HCQ-01) - Hydroxychloroquine study

Medical Research Council0 sitesJanuary 18, 2008

ConditionsHIV infection MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

DrugsPlaquenil

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV infection
Sponsor: Medical Research Council
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 18, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Medical Research Council

Eligibility Criteria

Inclusion Criteria

•1\. Documented HIV infection on ELISA and confirmatory test
•2\. Age 18 to 60 years
•3\. Naïve to antiretroviral therapy 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 6 months prior to screening.
•5\. Plasma HIV RNA viral load greater than 1000 copies/ml on screening blood
•6\. Willing and able to provide written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•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.
•10\. A woman who is currently pregnant or breastfeeding