Study to evaluate virological efficacy, safety tolerability of the to 2-drug therapy with DTG/3TC FDC or the antiretroviral tenofovir (TAF or TDF) -containing regimen (T-CR) in HIV-1 infected virologically suppressed women

Multi-center study to evaluate virological efficacy, safety tolerability, drug exposure and patients’ reported outcomes over 48 weeks following randomization to 2-drug therapy with DTG/3TC FDC or continuing current antiretroviral tenofovir (TAF or TDF)-containing regimen (T-CR) in HIV-1 infected virologically suppressed women - Multi-center study to evaluate virological efficacy, safety tolerability, drug exposure and patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002565-17-IT

Enrollment

290

Registered

2021-10-18

Start date

2021-12-02

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

HIV-1-infected adult women of >18 years of age, without previous virologic failure, currently receiving an effective (HIV-RNA < 50 copies/ml) triple-drug cART, containing tenofovir (TAF or TDF) in the regimen MedDRA version: 20.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: DOVATO - 50 MG / 300 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE Product Name: Dolutegravir (DTG) - lamivudine (3TC) Product Code: [DTG/3TC] Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major inclusion criteria: · Female individuals · HIV-1 documented infection · Age > 18 years · Being on an effective (pVL =65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: Major exclusion criteria: · Having failed virologically any previous ART regimen · Evidence of any 3TC (presence of M184V/I or K65R/E/N) or INSTI resistance · Having ever been treated with mono or dual ARV therapies subsequently intensified to three-drug cART regimen · Pregnancy or breast-feeding or not willing to use effective contraception if they are of child-bearing potential · An active malignancy or OI requiring active treatment (prophylactic regimens are allowed) · HBV infection · A life expectancy < 2 years

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate efficacy of switching to a two-drug one-pill regimen with DTG/3TC compared to maintaining the three-drugs regimen in women currently receiving any three-drug regimen containing Tenovofir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) who are virologically suppressed. Primary analysis will be performed after 48 weeks on the ITT population, according to the FDA snapshot algorithm;Secondary Objective: A) Safety B) Patient reported outcomes (PRO) C) Pharmacokinetics D) Virological paramethers E) Immunological paramethers: F) Viral Resistance G) Drug interaction benefit H) On a subset of participant (25 per arm) a substudy on cervico-vaginal shedding of HIV-RNA and inflammation markers will be performed in order to identify the different risk of viral genital shedding in the two arms;Primary end point(s): 1. Proportion of patients maintaining a HIV-RNA < 50 copies/ml according to FDA snapshot algorithm at 48 weeks according to an ITT NC = failure approach in which all randomized patients will be included and considered failures independently of the reason they did not complete the follow-up. The sample size has been calculated on this end-point according to a non-inferiority design. 2. At 48 weeks, a secondary analysis will be performed according a per protocol (PP) approach. In this case only patients fulfilling protocol-defined timeline and continuing to take the randomized therapy will be considered;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Main Objective: To evaluate efficacy of switching to a two-drug one-pill regimen with DTG/3TC compared to maintaining the three-drugs regimen in women currently receiving any three-drug regimen containing Tenovofir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) who are virologically suppressed. Primary analysis will be performed after 48 weeks on the ITT population, according to the FDA snapshot algorithm;Secondary Objective: A) Safety B) Patient reported outcomes (PRO) C) Pharmacokinetics D) Virological paramethers E) Immunological paramethers: F) Viral Resistance G) Drug interaction benefit H) On a subset of participant (25 per arm) a substudy on cervico-vaginal shedding of HIV-RNA and inflammation markers will be performed in order to identify the different risk of viral genital shedding in the two arms;Primary end point(s): 1. Proportion of patients maintaining a HIV-RNA < 50 copies/ml according to FDA snapshot algorithm at 48 weeks according to an ITT NC = failure approach in which all randomized patients will be included and considered failures independently of the reason they did not complete the follow-up. The sample size has been calculated on this end-point according to a non-inferiority design. 2. At 48 weeks, a secondary analysis will be performed according a per protocol (PP) approach. In this case only patients fulfilling protocol-defined timeline and continuing to take the randomized therapy will be considered;Timepoint(s) of evaluation of this end point: 48 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Change in protein-creatinine ratio (PCR), at baseline and at week 48 2. Change in fasting lipids parameters (TC, LDL, HDL, TC/HDL), at baseline and at week 48. A descriptive analysis of all reported AEs and a quantitative analysis of AEs leading to treatment interruption/change will be used to evaluate long-term tolerability of the simplification treatment 3. Change in metabolic parameters: 1) HOMA-IR; 2) BMI; 3) metabolic syndrome (according to International Diabetes Federation definition) at baseline, at week 24 and week 48. 4. Change of self-reported adherence level and proportion of patients with different adherence level (95%; 90%; 80%) at baseline and at week 48. 5. Change in QoL (HIVDQOL) and PROs items from baseline to week 48 by standardized validate self-reported questionnaires: treatment satisfaction [HIVTSQ], Health Status [EQ-5D-5L], adherence [ACTG modified questionnaire], symptoms [HIVSRQ], wellbeing [W-BQ16] 6. Change in neuropsychiatric questionnaire assessment on different items: a) anxiety (Beck Anxiety Inventory); b) depression (Beck Depression Inventory); c) other psychiatric symptoms (SCID, module B); d) sleep quality (Pittsburgh sleep quality index PSQI); e) suicidality risk (C-SSRS) 7. 3TC and DTG plasma concentrations (Cthrough) 8. Change in CD4+ and CD8+ T-lymphocyte count (absolute and percentage), and in CD4+/CD8+ ratio in the peripheral blood from baseline and week 48 9. Change in markers of inflammation and immune activation 10. Percentage of subjects with HIV-1 RNA <2.5 copies/mL at week 48 by ultrasensitive assay 11. Change in total viral HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) at baseline and at week 48 12. Change in viral shedding in vaginal swab at baseline and at week 48 13. Change in inflammatory cytokine in vaginal swab at baseline and at week 48 14. Proportion of patients developing resistance-conferring mutations (to NRTI, NNRTI or INSTI drug class) will be cumulatively described thro	—

Measure

Time frame

Secondary end point(s): 1. Change in protein-creatinine ratio (PCR), at baseline and at week 48 2. Change in fasting lipids parameters (TC, LDL, HDL, TC/HDL), at baseline and at week 48. A descriptive analysis of all reported AEs and a quantitative analysis of AEs leading to treatment interruption/change will be used to evaluate long-term tolerability of the simplification treatment 3. Change in metabolic parameters: 1) HOMA-IR; 2) BMI; 3) metabolic syndrome (according to International Diabetes Federation definition) at baseline, at week 24 and week 48. 4. Change of self-reported adherence level and proportion of patients with different adherence level (95%; 90%; 80%) at baseline and at week 48. 5. Change in QoL (HIVDQOL) and PROs items from baseline to week 48 by standardized validate self-reported questionnaires: treatment satisfaction [HIVTSQ], Health Status [EQ-5D-5L], adherence [ACTG modified questionnaire], symptoms [HIVSRQ], wellbeing [W-BQ16] 6. Change in neuropsychiatric questionnaire assessment on different items: a) anxiety (Beck Anxiety Inventory); b) depression (Beck Depression Inventory); c) other psychiatric symptoms (SCID, module B); d) sleep quality (Pittsburgh sleep quality index PSQI); e) suicidality risk (C-SSRS) 7. 3TC and DTG plasma concentrations (Cthrough) 8. Change in CD4+ and CD8+ T-lymphocyte count (absolute and percentage), and in CD4+/CD8+ ratio in the peripheral blood from baseline and week 48 9. Change in markers of inflammation and immune activation 10. Percentage of subjects with HIV-1 RNA <2.5 copies/mL at week 48 by ultrasensitive assay 11. Change in total viral HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) at baseline and at week 48 12. Change in viral shedding in vaginal swab at baseline and at week 48 13. Change in inflammatory cytokine in vaginal swab at baseline and at week 48 14. Proportion of patients developing resistance-conferring mutations (to NRTI, NNRTI or INSTI drug class) will be cumulatively described thro

—

Countries

Italy

Contacts

Public ContactInformazione sulla Sperimentazione

Clinical Research Technology

woddol@cr-technology.com0897724155

Outcome results

None listed

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