STUDY ABOUT THE USE OF THE TECHNIQUE FOR DETERMINING HIV TROPISM IN PATIENTS WITH UNDETECTABLE VIRAL LOAD TO GUIDE TREATMENT WITH A CCR5-ANTAGONIST DRUG.

Use of genotypic HIV-1 tropism testing in proviral DNA to guide CCR5 antagonist treatment in subjects with undetectable HIV-1 viremia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000799-32-ES

Enrollment

135

Registered

2011-11-03

Start date

2011-06-08

Completion date

Unknown

Last updated

2014-06-02

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

Conditions

Human immunodeficiency virus (HIV) infection. MedDRA version: 14.0 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: CELSENTRI 150 mg comprimidos recubiertos con película Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MARAVIROC Other descriptive name: MARAVIROC Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult (18 years or more), HIV-1 infected patients. Antiretroviral treatment for at leasdt 6 months containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) plus 1 Non-nucleoside reverse-transcriptase inhibitor (NNRTI) or 1 protease inhibitor (PI) or 1 integrase inhibitor (ININ) Viral load under 50 copies/mL in the last 6 months Patients with CCR5 tropism based in V3 genotyping in proviral DNA using the G2P with a false positive rate of 10% interpretation method. A change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (PI, NNRTI or ININ), according to investigator criteria. 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 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135

Exclusion criteria

Exclusion criteria: Pregnancy or breast-feeding. Patient previously treated with maraviroc. Patients with documented resistance to maraviroc or any other drug considered for the new ARV regimen. Viral failure in the moment of inclusion. Bad adherence history or anticipated (investigator criteria).

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess whether the determination of viral tropism from proviral DNA in PBMCs is a suitable technique to guide treatment with CCR5 antagonists in patients with undetectable viral load who need antiretroviral treatment change for reasons of tolerability or adverse effects.;Secondary Objective: 1. To evaluate the virological efficacy of a treatment. 2. Evaluate other aspects related to the maintenance of virologic response. 3. Assess changes in the tropism of HIV-1 during the study. 4. Assess the tolerability and safety of a treatment.;Primary end point(s): Sustained virologic suppression at 48 weeks of treatment (viral load).;Timepoint(s) of evaluation of this end point: Week 48	—

Measure

Time frame

Main Objective: Assess whether the determination of viral tropism from proviral DNA in PBMCs is a suitable technique to guide treatment with CCR5 antagonists in patients with undetectable viral load who need antiretroviral treatment change for reasons of tolerability or adverse effects.;Secondary Objective: 1. To evaluate the virological efficacy of a treatment. 2. Evaluate other aspects related to the maintenance of virologic response. 3. Assess changes in the tropism of HIV-1 during the study. 4. Assess the tolerability and safety of a treatment.;Primary end point(s): Sustained virologic suppression at 48 weeks of treatment (viral load).;Timepoint(s) of evaluation of this end point: Week 48

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Secondary

Measure	Time frame
Secondary end point(s): Evaluate other aspects related to the maintenance of virologic response. - Percentage of patients without confirmed virologic failure - Time to confirmed virological failure - Time to loss of virologic response (TLOVR) <200 copies / mL. - Time to loss of virologic response (TLOVR) <50 copies / mL. - Proportion of patients with undetectable viral load (VL <50 copies / mL) after 12, 24, 36 and 48 weeks of treatment with antiretroviral scheme including maraviroc. - Time to discontinuation of treatment, general and due to factors other than loss of virologic response. - Median change in CD4 count at weeks 12, 24, 36 and 48 compared with baseline. Assess changes in HIV-tropism: - Association between the level of detection of CCRX4 by 454 ultra deep sequencing in the screening and virologic response to antiretroviral scheme including maraviroc. - Change in proviral tropism by poblational genotyping and by 454 ultra deep sequencing genotyping in 35 randomly-selected patients. - Assessment of viral diversity and the level of CXCR4 using 454 ultra deep sequencing at week 12 and at the time of virologic failure (only in cases of virologic failure.) To assess the tolerability and safety of antiretroviral regimen including a CCR5 antagonist. - Median changes in fasting lipid parameters (total cholesterol, LDL and HDL, and triglycerides) compared with baseline. - Changes in liver function tests (AST, ALT, alkaline phosphatase and total bilirubin). - Cumulative number of adverse events at weeks 4, 12, 24, 36 and 48. - Cumulative number of grade 3-4 adverse events at weeks 4, 12, 24, 36 and 48. - Proportion of patients who prematurely terminated and reason for termination.;Timepoint(s) of evaluation of this end point: Screening, baseline, week 4, week 12, week 24, week 36 and week 48.	—

Measure

Time frame

Secondary end point(s): Evaluate other aspects related to the maintenance of virologic response. - Percentage of patients without confirmed virologic failure - Time to confirmed virological failure - Time to loss of virologic response (TLOVR) <200 copies / mL. - Time to loss of virologic response (TLOVR) <50 copies / mL. - Proportion of patients with undetectable viral load (VL <50 copies / mL) after 12, 24, 36 and 48 weeks of treatment with antiretroviral scheme including maraviroc. - Time to discontinuation of treatment, general and due to factors other than loss of virologic response. - Median change in CD4 count at weeks 12, 24, 36 and 48 compared with baseline. Assess changes in HIV-tropism: - Association between the level of detection of CCRX4 by 454 ultra deep sequencing in the screening and virologic response to antiretroviral scheme including maraviroc. - Change in proviral tropism by poblational genotyping and by 454 ultra deep sequencing genotyping in 35 randomly-selected patients. - Assessment of viral diversity and the level of CXCR4 using 454 ultra deep sequencing at week 12 and at the time of virologic failure (only in cases of virologic failure.) To assess the tolerability and safety of antiretroviral regimen including a CCR5 antagonist. - Median changes in fasting lipid parameters (total cholesterol, LDL and HDL, and triglycerides) compared with baseline. - Changes in liver function tests (AST, ALT, alkaline phosphatase and total bilirubin). - Cumulative number of adverse events at weeks 4, 12, 24, 36 and 48. - Cumulative number of grade 3-4 adverse events at weeks 4, 12, 24, 36 and 48. - Proportion of patients who prematurely terminated and reason for termination.;Timepoint(s) of evaluation of this end point: Screening, baseline, week 4, week 12, week 24, week 36 and week 48.

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Countries

Spain

Contacts

Public ContactUnitat VIH

Fundació Lluita contra la SIDA

rescrig@fls-rs.com+3493497 88 49

Outcome results

None listed

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