Study of pharmacological characteristics of antiretroviral drugs atazanavir/ritonavir and maraviroc in stable HIV-positive patients

MARAT Study “Pharmacokinetics of MARaviroc and boosted ATazanavir dual regimen in stable HIV-infected patients” - MARAT

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004692-22-IT

Enrollment

Registered

2015-01-15

Start date

2015-11-19

Completion date

Unknown

Last updated

2018-03-12

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

Conditions

HIV infection

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: MARAVIROC CAS Number: 376348-65-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical Form: Capsul

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -age>18 years; -confirmed HIV-antibodies positivity; -signed informed consent; -HIV-RNA=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: -active opportunistic infections or neoplasms; -need for drugs with known drug to drug interactions with included drugs (rifampicin, proton pump inhibitors); -liver cirrhosis; -any evidence of tropism for CXCR4 or dual infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe pharmacokinetics of maraviroc 300 mg and atazanavir/ritonavir 200/100mg qd in HIV stable patients;Secondary Objective: -evaluate viral suppression at week 60; -evaluate CD4 count at week 60; -changes in bone mineral density, bone metabolism markers, glomerular and tubular renal function; -changes in lipid metabolism markers; -changes in bilirubina level.;Primary end point(s): Percentage of patients with maraviroc Ctrough>50 ng/ml and atazanavir Ctrough>150 ng/ml.;Timepoint(s) of evaluation of this end point: week 4, week 16.	—

Measure

Time frame

Main Objective: To describe pharmacokinetics of maraviroc 300 mg and atazanavir/ritonavir 200/100mg qd in HIV stable patients;Secondary Objective: -evaluate viral suppression at week 60; -evaluate CD4 count at week 60; -changes in bone mineral density, bone metabolism markers, glomerular and tubular renal function; -changes in lipid metabolism markers; -changes in bilirubina level.;Primary end point(s): Percentage of patients with maraviroc Ctrough>50 ng/ml and atazanavir Ctrough>150 ng/ml.;Timepoint(s) of evaluation of this end point: week 4, week 16.

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Secondary

Measure	Time frame
Secondary end point(s): -percentage of patients with HIV-RNA< 20 copies/ml at week 60; - modification in CD4 count; -modification in bone mineral density (DEXA femur and spine); -modification in bone metabolism markers (bALP and vitamin D, PTH); -modification of proteinuria, glycosuria, fosfaturia and GFR; -modification in total, HDL, LDL cholesterol and triglycerides; -changes in total bilirubina levels.;Timepoint(s) of evaluation of this end point: - week 0 and 60, -week 0, 4,12,24,36,48 and 60; -baseline and week 60; -baseline and week 24, 60; -baseline and week 60; -baseline and week 24 and 60; -baseline and week 12,36,60.	—

Measure

Time frame

Secondary end point(s): -percentage of patients with HIV-RNA< 20 copies/ml at week 60; - modification in CD4 count; -modification in bone mineral density (DEXA femur and spine); -modification in bone metabolism markers (bALP and vitamin D, PTH); -modification of proteinuria, glycosuria, fosfaturia and GFR; -modification in total, HDL, LDL cholesterol and triglycerides; -changes in total bilirubina levels.;Timepoint(s) of evaluation of this end point: - week 0 and 60, -week 0, 4,12,24,36,48 and 60; -baseline and week 60; -baseline and week 24, 60; -baseline and week 60; -baseline and week 24 and 60; -baseline and week 12,36,60.

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Countries

Italy

Contacts

Public ContactAndrea Calcagno

University of Torino

andrea.calcagno@unito.it

Outcome results

None listed

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