Efficacy of the treatment with hydroxychloroquine in non responders HIV-infected HAART-treated patients - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012499-28-IT

Enrollment

Registered

2009-08-11

Start date

2009-08-07

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection (immunological nonresponders). MedDRA version: 9.1 Level: LLT Classification code 10008922

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Hydroxychloroquine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years of age or older patients, HIV positive with CD4 nadir pre-HAART=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Chronic liver disease, cardiopathy, retinopathy, known hypersensitivity to chloroquine and hydroxychloroquine, G6PDH deficit and pregnant and/or nursing women.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy oh hydroxychloroquine in increasing CD4 Tcells (50% campared to baseline) in a cohort of HIV-infected patients immunological non responders to HAART therapy.;Secondary Objective: To determine tolerability and safety of hydroxychloroquine treatment in the HIV-infected HAART-treated subjects enrolled in the study and efficacy of hydroxychloroquine in reducing T CD4+ cell apoptosis and T cell activation.;Primary end point(s): Absolute CD4 Tcells increase (>50% increase compared to baseline).	—

Measure

Time frame

Main Objective: To evaluate the efficacy oh hydroxychloroquine in increasing CD4 Tcells (50% campared to baseline) in a cohort of HIV-infected patients immunological non responders to HAART therapy.;Secondary Objective: To determine tolerability and safety of hydroxychloroquine treatment in the HIV-infected HAART-treated subjects enrolled in the study and efficacy of hydroxychloroquine in reducing T CD4+ cell apoptosis and T cell activation.;Primary end point(s): Absolute CD4 Tcells increase (>50% increase compared to baseline).

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026