Dual therapy in HIV patients in 4 days a week versus 7 days a week

Randomized, open-label and multicentric trial evaluating the non-inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy ANRS 177 DUETTO. - ANRS177DUETTO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003951-13-FR

Enrollment

440

Registered

2021-02-18

Start date

2021-04-19

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

HIV infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: TIVICAY Pharmaceutical Form: Film-coated tablet CAS Number: 1051375-16-6 Other descriptive name: DOLUTEGRAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • HIV-1 infection, coinfection HIV-1/HIV-2 possible • Age=18 years old • Current dual therapy unchanged for the last 6 months with Dolutegravir/ Lamivudine or Dolutegravir / Rilpivirine or Darunavir/r / Lamivudine • If a genotype is available in the patient medical history; virus must be susceptible to all on going dual therapy. If no ARN genotype available, the patients can be included in the study • Viral load (VL) 250/mm3 at W-4 • Estimated glomerular filtration rate > 60 mL/min (CKD-EPI method) • AST et ALT 10 g/dL • Platelets > 100 000/mm3 • For women of childbearing age, negative pregnancy plasmatic test at W-4 and agree to use efficacy contraception during the study • Commitment to use sexual prevention and protection methods throughout the trial. • Social security system coverage (including State Medical Aid (AME), if EC approves it. • Informed consent form signed 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 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Infection by HIV-2 • Chronic and active Viral B Hepatitis with positive antigen HBs • Chronic and active Viral C Hepatitis with treatment expected in the next 48 weeks • Concomitant treatment using interferon, interleukins, any other immune-therapy or chemotherapy, antivitamin K+ with co-treatment by booster • Concomitant prophylactic or curative treatment for an opportunistic infection • All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with study protocol compliance, observance and/or study treatment tolerance • Pregnant or breast feeding women • Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the non-inferiority at 48 weeks of dual therapy including Dolutegravir / Lamivudine or Dolutegravir / Rilpivirine or Darunavir/r/Lamivudine 4 consecutive days per week vs a dual therapy 7 days per week in HIV-controlled patients (Viral load 50 c/mL at 2 to 4 weeks apart or a viral load > 50 c/ml with a definitive stop of the study follow-up or the study strategy ;Timepoint(s) of evaluation of this end point: At week 48	—

Measure

Time frame

Main Objective: To evaluate the non-inferiority at 48 weeks of dual therapy including Dolutegravir / Lamivudine or Dolutegravir / Rilpivirine or Darunavir/r/Lamivudine 4 consecutive days per week vs a dual therapy 7 days per week in HIV-controlled patients (Viral load 50 c/mL at 2 to 4 weeks apart or a viral load > 50 c/ml with a definitive stop of the study follow-up or the study strategy ;Timepoint(s) of evaluation of this end point: At week 48

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of participants with therapeutic success until W48 • Percentage of participants with at least one episode of "blip" (viral load >50 copies/mL followed by a control value = 50 cp/mL) between W0 and W48 • Percentage of participants with a viral load signal detected between W0 and W48 • Evolution of ultrasensitive viral load and total DNA in the PBMC at W0 and W48 (immuno-virological sub-study) • Proportion of participants with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by NGS • Description of selected mutations at the virological failure • Frequency of minority resistant variants archived in DNA at W0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations • Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE) • Evolution of T CD4 and CD8 cells count, and CD4/CD8 ratio from W-4 to W48 • Evolution of fasting metabolic parameters (total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia) until W0 and W48 • Evolution of weight between W0 and W48 • Evolution of inflammation serum parameters - immuno-virological sub-study- (sCD14, sCD163, IP-10, CRPus, IL-6, D-dimers, sTNFR1, sTNFR2) from W0 to W24 and W48 (150 participants forecast) • Evolution of semen viral load at W0, W24 and W48 (120 participants forecast). • Description and comparison of plasmatic concentrations of antiretroviral agents between the 2 groups at ON and OFF period • Evaluation of the adherence by self-reported questionnaire at W0, W8, W24, W36 and W48 • Evolution of the quality of life by self-reported questionnaire between W-4 and W48 ;Timepoint(s) of evaluation of this end point: Evaluation throughout the trial	—

Measure

Time frame

Secondary end point(s): • Proportion of participants with therapeutic success until W48 • Percentage of participants with at least one episode of "blip" (viral load >50 copies/mL followed by a control value = 50 cp/mL) between W0 and W48 • Percentage of participants with a viral load signal detected between W0 and W48 • Evolution of ultrasensitive viral load and total DNA in the PBMC at W0 and W48 (immuno-virological sub-study) • Proportion of participants with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by NGS • Description of selected mutations at the virological failure • Frequency of minority resistant variants archived in DNA at W0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations • Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE) • Evolution of T CD4 and CD8 cells count, and CD4/CD8 ratio from W-4 to W48 • Evolution of fasting metabolic parameters (total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia) until W0 and W48 • Evolution of weight between W0 and W48 • Evolution of inflammation serum parameters - immuno-virological sub-study- (sCD14, sCD163, IP-10, CRPus, IL-6, D-dimers, sTNFR1, sTNFR2) from W0 to W24 and W48 (150 participants forecast) • Evolution of semen viral load at W0, W24 and W48 (120 participants forecast). • Description and comparison of plasmatic concentrations of antiretroviral agents between the 2 groups at ON and OFF period • Evaluation of the adherence by self-reported questionnaire at W0, W8, W24, W36 and W48 • Evolution of the quality of life by self-reported questionnaire between W-4 and W48 ;Timepoint(s) of evaluation of this end point: Evaluation throughout the trial

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Countries

France

Contacts

Public ContactCécile MOINS

INSERM-ANRS

cecile.moins@anrs.fr33144236027

Outcome results

None listed

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