Studio degli effetti immuno-virologici dell’interruzione di Maraviroc nei pazienti che stanno fallendo un regime contenente Maraviroc

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021651-79-IT

Enrollment

Registered

2012-04-13

Start date

2011-03-22

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

patients affected by HIV in stable treatment with Maraviroc from at least 6 months MedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: CELSENTRI*60CPR RIV 150MG Pharmaceutical Form: Coated tablet INN or Proposed INN: celsentri Concentration unit: mg milligram(s) Concentration number: 150- Trade Name: EMTRIVA*1FL 30CPS 20

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •age > 18 years •HIV infected, antiretroviral experienced patients •Stable HAART regimen containing maraviroc for at least 6 months •Confirmed (two consecutive determinations) HIV-1 RNA>50 copies/ml •Genotypic Sensitivity Score =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Pregnancy and breast feeding women • Immediate availability of an effective HAART • Acute illness that in the opinion of the investigator might be aggravated by a partial interruption of antiretroviral treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate viral evolution of patients failing maraviroc;Secondary Objective: Viral evolution will be evaluated as: 1) Proportion of patients that switch viral tropism at EOS compared to baseline. 2) Frequency and change of mutations in the V3 region of Env associated with resistance to maraviroc at EOS compared to baseline 3) Change of viral tropism of the V3 region of Env between screening and baseline 4) Change of mutational pattern of the V3 region of Env between screening and baseline 5)Immunological impact of maraviroc will be evaluated as: -Change in the absolute number of CD4+ T cells from baseline. -Change in the percentage of CD4+ T cells from baseline. -Change in the percentage activated T cells (CD38+ HLA-DR+ CD4+ and CD8+ cells) CCR5+ and CXCR4+ Naïve and Memory cells, from baseline.;Primary end point(s): Proportion of patients with an increase of at least 0.5 Log10 in HIV-1 RNA at W12.	—

Measure

Time frame

Main Objective: To evaluate viral evolution of patients failing maraviroc;Secondary Objective: Viral evolution will be evaluated as: 1) Proportion of patients that switch viral tropism at EOS compared to baseline. 2) Frequency and change of mutations in the V3 region of Env associated with resistance to maraviroc at EOS compared to baseline 3) Change of viral tropism of the V3 region of Env between screening and baseline 4) Change of mutational pattern of the V3 region of Env between screening and baseline 5)Immunological impact of maraviroc will be evaluated as: -Change in the absolute number of CD4+ T cells from baseline. -Change in the percentage of CD4+ T cells from baseline. -Change in the percentage activated T cells (CD38+ HLA-DR+ CD4+ and CD8+ cells) CCR5+ and CXCR4+ Naïve and Memory cells, from baseline.;Primary end point(s): Proportion of patients with an increase of at least 0.5 Log10 in HIV-1 RNA at W12.

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Countries

Italy

Outcome results

None listed

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