n.a.

IMPACT ON BONE MINERAL DENSITY (BMD) OF TDF-SPARING ANTIRETROVIRAL REGIMENS IN HIV-POSITIVE MENOPAUSAL WOMEN AFFECTED BY OSTEOPENIA: THE TENOFOVIR SPARING STRATEGY (TESS) STUDY - TESS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000447-40-IT

Enrollment

194

Registered

2020-11-04

Start date

2017-07-12

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

HIV-positive women affected by osteopenia. MedDRA version: 20.0 Level: PT Classification code 10049088 Term: Osteopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862

Interventions

Trade Name: CELSENTRI - 150 MG COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (PVC/ALU) 60 COMPRESSE Product Name: Celsentri¿ Product Code: [xxxxxxx] Pharmaceutical Form: Film-coated tablet INN or P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.HIV-positive menopausal women with age between 40 and 75 years (menopausal state: patient-reported absent menstrual cycle since a minimum of 12 months); 2.affected by osteopenia at spine and/or femur site defined by T score = -1 SD and > -2,5. SD at DXA scan performed within 3 months prior to enrolment (see “DXA quality assurance program” in Annex 4, page 52 – Lab. 3); 3.ART with TDF+3TC or emtricitabine in association with either a boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor unchanged for at least 6 months; 4.viroimmunological markers (performed within 3 months prior to enrolment): HIV-RNA 200 cells/mmc; 5.eGFR >50 ml/min (estimated by MDRD formula); 6.patients harbouring a CCR5-tropic virus. In case of tropism data available in patient’s clinical history, there is no need to repeat the test: consider the last result as inclusion criteria. In case of missing data, testing must be conducted on HIV-DNA c/o Virology Lab Tor Vergata, on frozen blood sample collected within 6 months from screening (see Annex 4, page 53 – Lab. 4); 7.HBsAg negative by test performed within 6 months before enrolment; 8.willing to comply with all study procedures and be available for the duration of the study; 9.provide signed and dated informed consent form. 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 97 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 97

Exclusion criteria

Exclusion criteria: 1.previous diagnosis of AIDS dementia complex; 2.virological failure to prior DRV/r containing regimens; 3.history of mutations conferring resistance to DRV or 3TC; 4.CXCR4 or CCR5/CXCR4 dual tropic HIV tropism or a non-reportable tropism result; 5.previous virological failure to MRV; 6.HCV active infection with ongoing or planned treatment with DAA drugs known to show interactions with ART drugs in study; 7.previous (within 1 year) or ongoing biphosfonate therapy; 8.ongoing estro-progestinic therapy; 9.ongoing or less than 30 days prior corticosteroids or immunosuppressive therapy; 10.history of pathologic fracture; 11.known allergic reactions to study drugs; 12.treatment with any other investigational drug; 13.anything that, in the opinion of the investigator, would place the subject at increased risk or reclude the subject’s full compliance with or completion of the study; 14. patients with decompensated liver diseases (Child Pugh Score: B9).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate whether in menopausal HIV-positive women affected by osteopenia switch from a TDF-containing cART to a TDF-sparing strategy (TSS) based on darunavir/ritonavir and maraviroc (DRV/r+MRV) is superior in terms of increasing BMD at the spine or femur site to a TSS based on DRV/r and lamivudine (DRV/r+3TC).;Secondary Objective: Secondary objectives of the study are to compare the two TSS with regard to the following: •viroimmunologic response, by plasma HIV-RNA and CD4+ T-cell count; •change of bone turnover markers and of osteoclastogenic cytokines between baseline and the end of the study (18 months); •change in the 10 year probability of fracture (hip and/or major osteoporotic fracture); assessed by WHO fracture risk assessment tool (FRAX¿) between baseline and the end of the study (18 months); •change in the amount of CD4+ T-lymphocytes HIV-DNA after 18 months of therapy; •to assess the change of inflammation markers involved in bone homeostasis and of T-cell immune-activation markers after 18 months of treatment; •to assess the change of glomerular filtration rate, estimated by MDRD formula, after 18 months of treatment (eGFR); •plasma trough concentration of antiretroviral drugs (MRV, DRV and ritonavir); •study of tropism change in case of virological failure.;Primary end point(s): The primary objective of the study is to evaluate whether in menopausal HIV-positive women affected by osteopenia switch from a TDF-containing cART to a TDF-sparing strategy (TSS) based on darunavir/ritonavir and maraviroc (DRV/r+MRV) is superior in terms of increasing BMD at the spine or femur site to a TSS based on DRV/r and lamivudine (DRV/r+3TC).;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate whether in menopausal HIV-positive women affected by osteopenia switch from a TDF-containing cART to a TDF-sparing strategy (TSS) based on darunavir/ritonavir and maraviroc (DRV/r+MRV) is superior in terms of increasing BMD at the spine or femur site to a TSS based on DRV/r and lamivudine (DRV/r+3TC).;Secondary Objective: Secondary objectives of the study are to compare the two TSS with regard to the following: •viroimmunologic response, by plasma HIV-RNA and CD4+ T-cell count; •change of bone turnover markers and of osteoclastogenic cytokines between baseline and the end of the study (18 months); •change in the 10 year probability of fracture (hip and/or major osteoporotic fracture); assessed by WHO fracture risk assessment tool (FRAX¿) between baseline and the end of the study (18 months); •change in the amount of CD4+ T-lymphocytes HIV-DNA after 18 months of therapy; •to assess the change of inflammation markers involved in bone homeostasis and of T-cell immune-activation markers after 18 months of treatment; •to assess the change of glomerular filtration rate, estimated by MDRD formula, after 18 months of treatment (eGFR); •plasma trough concentration of antiretroviral drugs (MRV, DRV and ritonavir); •study of tropism change in case of virological failure.;Primary end point(s): The primary objective of the study is to evaluate whether in menopausal HIV-positive women affected by osteopenia switch from a TDF-containing cART to a TDF-sparing strategy (TSS) based on darunavir/ritonavir and maraviroc (DRV/r+MRV) is superior in terms of increasing BMD at the spine or femur site to a TSS based on DRV/r and lamivudine (DRV/r+3TC).;Timepoint(s) of evaluation of this end point: 18 months

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary objectives of the study are to compare the two TSS with regard to the following: •viroimmunologic response, by plasma HIV-RNA and CD4+ T-cell count; •change of bone turnover markers and of osteoclastogenic cytokines between baseline and 18 months of follow-up; •change in the 10 year probability of fracture (hip and/or major osteoporotic fracture) assessed by WHO fracture risk assessment tool (FRAX¿) between baseline and 18 months of follow-up; •change in the amount of CD4+ T-lymphocytes HIV-DNA after 18 months of therapy; •to assess the change of inflammation markers involved in bone homeostasis and of T-cell immune-activation markers after 18 months of treatment; •to assess the change of glomerular filtration rate, estimated by MDRD formula, after 18 months of treatment (eGFR); •plasma trough concentration of antiretroviral drugs (MRV, DRV and ritonavir); •study of tropism change in case of virological failure.;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Secondary end point(s): Secondary objectives of the study are to compare the two TSS with regard to the following: •viroimmunologic response, by plasma HIV-RNA and CD4+ T-cell count; •change of bone turnover markers and of osteoclastogenic cytokines between baseline and 18 months of follow-up; •change in the 10 year probability of fracture (hip and/or major osteoporotic fracture) assessed by WHO fracture risk assessment tool (FRAX¿) between baseline and 18 months of follow-up; •change in the amount of CD4+ T-lymphocytes HIV-DNA after 18 months of therapy; •to assess the change of inflammation markers involved in bone homeostasis and of T-cell immune-activation markers after 18 months of treatment; •to assess the change of glomerular filtration rate, estimated by MDRD formula, after 18 months of treatment (eGFR); •plasma trough concentration of antiretroviral drugs (MRV, DRV and ritonavir); •study of tropism change in case of virological failure.;Timepoint(s) of evaluation of this end point: 18 months

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Countries

Italy

Contacts

Public ContactClinica Malattie Infettive Tropical

ASST Santi Paolo e Carlo

esther.merlini@gmail.com0281843061

Outcome results

None listed

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