Antiretroviral treatment with maraviroc plus ritonavir-boosted darunavir for early salvage therapy

Efficacy of dual antiretroviral treatment with maraviroc plus ritonavir-boosted darunavir in early rescue therapy in patients with HIV-1 infection: pilot, multicenter, randomized, controlled and open phase II clinical trial. BIMARTHE study - Bimarthe

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003501-10-ES

Enrollment

Registered

2013-01-09

Start date

2013-04-24

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

Adult patients with HIV-1 infection that present virologic failure to first-line antiretroviral treatment. MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Celsentri Pharmaceutical Form: Tablet INN or Proposed INN: MARAVIROC CAS Number: 376348-65-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Trade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients with HIV-1 infection - Virologic failure, definded as two consecutive HIV RNA levels > 400 cop/ml within 2-6 weeks, when being under stable ART for at least 3 months - Genotipic resistance to lamivudine/emtricitabine (M184V/I) irrespective of other NRTIs or NNRTIs associated mutations. Patients with current or previous virologic failure to an IP/r based regimen may be included if the number of IPs associated mutations is ? 2 and there are no IPs primary resistances or DRV associated mutations - CCR5 viral tropism determined by V3 sequencing. The period between the determination of viral tropism and inclusion in the study will be 6 weeks maximum - Informed consent - Women without reproductive potential and not breastfeeding. - Women with reproductive potential if they are not breastfeeding and who meet the following criteria: * Negative pregnancy test at baseline * Accept commit to avoid pregnancy until 30 days after the last dose of study drug, by using double barrier method of contraception or abstinence. 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 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - AIDS defining event within 48 weeks before starting study - Current HIV RNA load > 100.000 cop/ml - Current CD4+ cell count < 100 cel/mm³ - HBV coinfection (HBsAg positive) - Descompensated liver cirrhosis (Child-Pugh B/C) - Chronic renal failure (Clearance of creatinine MDRD < 30 ml/min/1,73m2) - Patients unable to understant the study prtocol or candidates who, in researcher opinion, are not appropiate to be enroled in the study - Pregnant, lactating or with reproductive potential women, who not commit to avoid pregnancy until 30 days after the last dose of study drug.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effectiveness of a combination of maraviroc (150mg QD) plus DRV/r (800/100mg QD) versus a standard regimen with three antiretroviral drugs at week 48 of treatment, in patients infected with human immunodeficiency virus (HIV +) with CCR5 tropism that presented virologic failure with first-line antiretroviral treatment;Secondary Objective: - Effectiveness of both regimens at weeks 12 and 24 of treatment - Time to treatment failure - Change in the CD4+ count at weeks 12, 24 and 48 of treatment - Safety of both regimens - Cost-effectiveness study of both regimens, defined as the average treatment cost for each patient with undetectable viral load at week 48 (patients with undetectable viral load/total number of patients treated) - Incidence and type of resistance mutations appeared in those patients with virologic failure - Pharmacokinetic analysis of darunavir, ritonavir and maraviroc in patients assigned to the experimental group;Primary end point(s): Proportion of patients with undetectable viral load (<50 copies/ml) at 48 weeks follow-up, according to time to loss of virologic response (TLOVR) algorith by intention to treat analysis. Lost patients or changes in study drugs will be considered treatment failures (loss and changes = failure).;Timepoint(s) of evaluation of this end point: At 48 weeks follow-up	—

Measure

Time frame

Main Objective: To compare the effectiveness of a combination of maraviroc (150mg QD) plus DRV/r (800/100mg QD) versus a standard regimen with three antiretroviral drugs at week 48 of treatment, in patients infected with human immunodeficiency virus (HIV +) with CCR5 tropism that presented virologic failure with first-line antiretroviral treatment;Secondary Objective: - Effectiveness of both regimens at weeks 12 and 24 of treatment - Time to treatment failure - Change in the CD4+ count at weeks 12, 24 and 48 of treatment - Safety of both regimens - Cost-effectiveness study of both regimens, defined as the average treatment cost for each patient with undetectable viral load at week 48 (patients with undetectable viral load/total number of patients treated) - Incidence and type of resistance mutations appeared in those patients with virologic failure - Pharmacokinetic analysis of darunavir, ritonavir and maraviroc in patients assigned to the experimental group;Primary end point(s): Proportion of patients with undetectable viral load (<50 copies/ml) at 48 weeks follow-up, according to time to loss of virologic response (TLOVR) algorith by intention to treat analysis. Lost patients or changes in study drugs will be considered treatment failures (loss and changes = failure).;Timepoint(s) of evaluation of this end point: At 48 weeks follow-up

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Secondary

Measure	Time frame
Secondary end point(s): - Time to virologic failure, calculated by Kaplan-Meier method, as well as median time to the event and the interquartile range. Time to failure in both groups will be compared using long-rank test. - Change in CD4+ and CD8+ cells count at weeks 12, 24 and 48 of treatment;Timepoint(s) of evaluation of this end point: Time to virologic failure in each patient enroled in the study CD4+ and CD8+ cells count at weeks 12, 24 and 48 of treatment	—

Measure

Time frame

Secondary end point(s): - Time to virologic failure, calculated by Kaplan-Meier method, as well as median time to the event and the interquartile range. Time to failure in both groups will be compared using long-rank test. - Change in CD4+ and CD8+ cells count at weeks 12, 24 and 48 of treatment;Timepoint(s) of evaluation of this end point: Time to virologic failure in each patient enroled in the study CD4+ and CD8+ cells count at weeks 12, 24 and 48 of treatment

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Countries

Spain

Contacts

Public ContactClinical Trials Information

Vall d'Hebron Institut de Recerca

mcrespo@vhebron.net++3493932746251

Outcome results

None listed

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