NCT01067417
Unknown
Phase 2
Evaluation of the Efficacy of Hydroxychloroquine in Decreasing Immune Activation in Asymptomatic HIV-infected Patients
Overview
- Phase
- Phase 2
- Sponsor
- Medical Research Council
- Enrollment
- 83
- Primary Endpoint
- 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+).
Overview
Brief Summary
The purpose of this pilot study is to find out if taking hydroxychloroquine will decrease immune activation (stimulation of the body's defence system) in people with early HIV infection. Hydroxychloroquine is a medicine that has been used successfully for many years to treat autoimmune diseases (diseases in which the immune system causes damage to the body), e.g. lupus and rheumatoid arthritis. It is generally safe in long-term use and easily accessible.
The immune system is stimulated in response to infections including HIV, so treatments that decrease immune activation may have long-term clinical benefits i.e. delay onset of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented HIV infection on ELISA and confirmatory test.
- •Age 18 to 65 years.
- •Naïve to antiretroviral therapy or off ART for at least 12 months prior to study entry.
- •CD4 T-cell count greater than 400 cells/µL on screening blood test and on one other test performed within the 6 months prior to screening.
- •Plasma HIV RNA viral load greater than 1000 copies/ml on screening blood test
- •Willing and able to provide written informed consent.
Exclusion Criteria
- •History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, glucose 6-phosphate dehydrogenase (G6PD) deficiency.
- •Insulin-dependent or non-insulin-dependent diabetes mellitus.
- •Chronic liver disease of any cause or alcoholism.
- •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).
- •Pneumonia, meningitis, septicaemia or any other serious infection in the 2 months prior to screening.
- •Any acute infection with fever and systemic symptoms within the last 24 hours.
- •Any vaccinations in the 2 months prior to screening.
- •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.
- •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.
- •A woman who is currently pregnant or breastfeeding.
Arms & Interventions
Hydroxychloroquine
Active Comparator
Intervention: Hydroxychloroquine (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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+).
Time Frame: week 48
Secondary Outcomes
No secondary outcomes reported
Investigators
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