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

• Conditions: HIV infection; MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2007-005057-36-GB
• Lead Sponsor: Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
test
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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
11. A woman of child-bearing potential who is planning to become pregnant during the course of the study, or is unwilling to take adequate contraception (including barrier contraception) throughout the course of the study.
12. Use of systemic corticosteroids or other immunomodulatory drugs within the 12 months prior to screening
13. Current use of medication with known serious hepatotoxic effects or known interaction with hydroxychloroquine.
14. Evidence of cardiac conduction defects or cardiac arrhythmia on screening ECG
15. Retinopathy or visual field changes detected on screening eye examination
16. Hepatitis B surface antigen (HBsAg) positive or Hepatitis C PCR positive (patients who are Hepatitis C antibody positive are allowed to participate provided that PCR is negative).
17. Any of the following laboratory abnormalities on screening blood test:
- Haemoglobin less than 10.5g/dl,
- Absolute neutrophil count less than 1.0x109/L
- Platelet count less than 100 X 109/L
- ALT or AST, or alkaline phosphatase above 2.5 x upper limit of normal (ULN)
- Serum creatinine greater than 1.5xULN
- Estimated creatinine clearance (Cockroft-Gault equation*) below 60ml/min
18. Inability to attend or comply with treatment or follow-up scheduling
19. Current participation in any other clinical intervention trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This is a pilot study to determine whether hydroxychloroquine decreases immune activation in HIV.;Secondary Objective: To determine whether hydroxychloroquine decreases viral load in HIV.;Primary end point(s): Change in CD8 T-cell activation at week 48 compared to baseline (as shown by a percentage of the cells expressing CD38+ and HLA-DR+).