HIV InfectionsPhase 2HCQ-01NCT01067417
Evaluation of the Efficacy of Hydroxychloroquine in Decreasing Immune Activation in Asymptomatic HIV-infected Patients
A Phase 2 study testing Hydroxychloroquine in people with HIV Infections, run by Medical Research Council.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Use of systemic corticosteroids or other immunomodulatory drugs within the 12 months prior to screening.
- Current use of medication with known serious hepatotoxic effects or known interaction with hydroxychloroquine.
- Evidence of cardiac conduction defects or cardiac arrhythmia on screening ECG.
- Retinopathy or visual field changes detected on screening eye examination.
- 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).
- 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 (Cockcroft-Gault equation*) below 60ml/min
- Inability to attend or comply with treatment or follow-up scheduling.
- Current participation in any other clinical intervention trial.
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- Hydroxychloroquine, Chloroquine, HIV Infection, Acquired Immunodeficiency Syndrome, Immune Activation, inflammation, treatment naive, disease progression
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Inflammation, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taken orally 2x200mg capsules once daily for 48 weeks
PlaceboDrug
Taken orally 2x200mg capsules once daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Active comparator | Not described Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+).
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJun 2008
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Collaborators
- Wellcome Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067417
- Sponsor's protocol ID
- HCQ-01
- Other IDs
- 2007-005057-36
- Acronym
- HCQ-01
- Status last verified
- Feb 2010
- First submitted
- 10 Feb 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Hydroxychloroquine in Decreasing Immune Activation in Asymptomatic HIV-infected Patients
- ClinicalTrials.gov ID
- NCT01067417
- Acronym / sponsor ID
- HCQ-01 / HCQ-01
- Conditions
- HIV Infections
- Keywords
- Hydroxychloroquine, Chloroquine, HIV Infection, Acquired Immunodeficiency Syndrome, Immune Activation, inflammation, treatment naive, disease progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- Wellcome Trust
- Study start
- Jun 2008
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Active comparator | Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineTaken orally 2x200mg capsules once daily for 48 weeks | Drug | Hydroxychloroquine |
| PlaceboTaken orally 2x200mg capsules once daily for 48 weeks | Drug | Placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine in people with HIV Infections, run by Medical Research Council.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2010.