A Phase 3 interventional study of Doravirine + tenofovir DF + lamivudine and Dolutegravir + tenofovir DF + lamivudine or emtricitabine in HIV-1-infection, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 19 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment
Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.
Phase III, multicenter, open-label, randomized, non-inferiority clinical trial which aims to assess the non-inferiority of doravirine in association with tenofovir and lamivudine, as compared to dolutegravir in association with tenofovir and lamivudine or emtricitabine.
This trial will be implemented in Brazil, Cameroon, Côte d'Ivoire, France, Mozambique and Thailand.
Six hundred and ten patients will be enrolled and followed for 96 weeks after entry in the trial (=ART initiation).
Primary endpoint will assess virological efficacy at Week 48, measured by the proportion of subjects achieving HIV-1 RNA \<50 copies/mL, in HIV-1 infected, treatment-naive subjects with pre-treatment viral load (HIV-1 RNA) ≥ 1,000 copies/mL.
Secondary endpoints are planned at W48 and W96.
ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non-inclusion Criteria:
Has the following laboratory values at screening visit, within 30 days prior to the randomization:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Doravirine (100 mg) + tenofovir DF (300 mg) + lamivudine (300mg) administered daily
Drug: Doravirine + tenofovir DF + lamivudine
Dolutegravir (50 mg) + tenofovir DF 300 mg + XTC (300 mg if lamivudine or 200 mg if emtricitabine) administered daily
Drug: Dolutegravir + tenofovir DF + lamivudine or emtricitabine
Drug pages: Doravirine · Tenofovir · Lamivudine
Oral administration
Also known as: Delstrigo
Oral administration
Non-inferiority of doravirine in combination with tenofovir and lamivudine as compared to dolutegravir in combination with tenofovir and lamivudine or emtricitabine in terms of virological efficacy at week 48
The non-inferiority will be assessed in terms of virologic efficacy at week 48 under allocated treatment using the FDA snapshot algorithm (window period of 42-54 weeks), and measured by the proportion of subjects achieving a rate of HIV 1 RNA \<50 copies/mL, in HIV-1 infected, treatment-naive subjects with pre-treatment viral load (HIV-1 RNA) ≥ 1,000 copies/mL. The rate of HIV 1 RNA will be measured by RT-PCR.
Time frame: Week 48
Occurrence of obesity
Obesity will be defined as having BMI≥30 kg/m² for Caucasian and African population and BMI≥27.5 kg/m² for Asian populations.
Time frame: Week 48; Week 96
Occurrence of insulin resistance
Proportion of subjects with newly measured HOMA≥2 as compared to baseline HOMA will be calculated with the following formula (glucose levels in mmol/L, insulin levels in mIU/L): HOMA =(glucose ×insulin)÷22.5
Time frame: Week 48; Week 96
Occurrence of hypertension
Proportion of subjects with hypertension newly detected compared to baseline. Hypertension will be defined as either being prescribed new anti-hypertension medication and/or by having diastolic blood pressure \>90 mmHg AND/OR systolic blood pressure \>140 mmHg during visit and confirmed during subsequent visit \> 15 days after.
Time frame: Week 48; Week 96
Non-inferiority of DOR in association with TDF and 3TC, compared to DTG in association with TDF and 3TC or FTC, in terms of virologic efficacy
Proportion of subjects in virologic success defined as achieving HIV-1 RNA \<50 copies/mL at week 96 under allocated treatment using the FDA snapshot algorithm with a window period of 90 to 102 weeks; subjects not achieving viral success will be described according to the FDA snapshot recommendation
Time frame: Week 96
Occurrence of virological failures
Proportion of confirmed virological failures. Virological failure will be defined as 1) confirmed HIV-1 RNA ≥ 200 copies/mL after initial response with HIV-1 RNA \< 50 copies/mL at any time during the study or 2) non-response defined as either confirmed HIV-1 RNA ≥ 200 copies/mL at Week 24 or Week 36 (or any other unscheduled visit in-between) or confirmed HIV-1 RNA ≥ 50 copies/mL at Week 48, Week 72 and Week 96 (or any other unscheduled visit in-between).
Time frame: Virological failure
Occurrence of HIV-1 drug resistances in patients with confirmed virological failure
Frequency of HIV-1 drug resistances in participants with a confirmed virological failure. Drug resistances will be defined according to the last version of the ANRS algorithm and to the last version of the Stanford algorithm.
Time frame: Virological Failure
Virological efficacy at a threshold of HIV 1 RNA<200 copies/mL
Proportion of subjects achieving HIV 1 RNA\<200 copies/mL under allocated treatment
Time frame: Week 48; Week 96
Virological efficacy at a threshold of HIV 1 RNA<1000 copies/mL
Proportion of subjects achieving HIV 1 RNA\<1000 copies/mL under allocated treatment
Time frame: Week 48; Week 96
Effect of baseline RT and integrase mutations on virological response
Frequency of RT and integrase mutations at baseline and impact on the virological response
Time frame: Week 48; Week 96
Occurrence of combined overweight and obesity
Combined overweight and obesity will be defined as having BMI≥25 kg/m² for Caucasian and African populations and BMI≥23 kg/m² for Asian populations
Time frame: Week 48; Week 96
Occurrence of weight gain ≥10% absolute body weight
Proportion of subjects with ≥10% absolute weight gain from baseline
Time frame: Week 48; Week 96
Changes in absolute weight gain
Absolute weight gain will be calculated by simply subtracting the follow-up weight from baseline weight measured according to protocol procedures
Time frame: Week 48; Week 96
Occurrence of diabetes
Proportion of subjects with diabetes newly detected compared to baseline. Diabetes will be defined as either being prescribed new medication for diabetes mellitus and/or having a fasting glycemia ≥1.26 g/L during visit and confirmed during subsequent visit \> 15 days after and/or in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).
Time frame: Week 48; Week 96
Safety and tolerability
Any adverse event of any grade and those graded 3-4
Time frame: Week 48; Week 96
Changes in waist circumference, hip circumference and waist-to-hip ratio
Change from baseline in waist and hip circumferences and waist-to-hip ratio
Time frame: Week 48; Week 96
Changes in fasting glycemia and insulin
Change from baseline in fasting glycemia and insulin
Time frame: Week 48; Week 96
Changes in fasting serum lipids
Change from baseline in fasting serum lipids. The fasting serum lipids analyzed will be total cholesterol, HDL, LDL and triglycerides.
Time frame: Week 48; Week 96
Changes in estimated glomerular filtration rate
Change from baseline in estimated glomerular filtration rate. Estimated glomerular filtration rate (eGFR) will be calculated using the CKD-EPI equation
Time frame: Week 48; Week 96
Occurrence of cardiovascular abnormalities
Change from baseline in cardiovascular parameters (blood pressure profile, electrocardiographic and echocardiographic damages). These cardiovascular parameters assessments will be measured through an electrocardiogram, a transthoracic echocardiography and an ABPM, a 24-hour blood pressure Holter.
Time frame: Week 48; Week 96
Changes in liver steatosis and clinically significant fibrosis
Change from baseline in mean patient CAP and LSM measurements and occurrence of: Liver steatosis defined by CAP ≥ 263 dB/m2, and clinically significant liver fibrosis and cirrhosis defined by LSM ≥ 8.0 kPa and LSM ≥ 12.5 kPa, respectively
Time frame: Week 48; Week 96
Occurrence of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic-associated steatohepatitis (MASH)
Change from baseline in mean patient CAP and LSM measurements and occurrence of: MASLD defined by the presence of liver steatosis with at least one cardiometabolic risk-factor (overweight/obesity; pre-or diabetes; hypertension; hypertriglyceridemia or low-HDL; and MASH defined by the presence of at least CSF in people with MASLD.
Time frame: Week 48; Week 96
Changes in liver diseases biomarkers
Changes from baseline in Fib-4, VCTE and FAST scores and presence at baseline or occurrence of: CSF defined as Fib-4 ≥ 2.67 and FAST score \> 0.67 (high probability of MASH)
Time frame: Week 48; Week 96
Changes in mental health and quality of life outcomes
Change from baseline in EQ-5D-3L, HIVTSQ, DASS-21, PSQI, WHOQOL HIV-BREF scores
Time frame: Week 24; Week 48; Week 96
Occurrence of Acquired Immune Deficiency Syndrome (AIDS), tuberculosis, Immune Reconstitution Inflammatory Syndrome (IRIS) or death
Proportion of subjects with AIDS (defined as having CDC stage 3/C or WHO stage 4), tuberculosis, IRIS or death
Time frame: Week 48; Week 96
Description of antiretroviral drugs trough plasma concentration in each arm
DOR, DTG and M9 trough plasma concentration in samples taken pre-dose
Time frame: Week 4; Week 24; Week 48; Week 96
Assessment of the effect of antiretroviral drugs trough plasma concentration on virological response
DOR, DTG and M9 trough plasma concentration in samples taken pre-dose
Time frame: Week 4; Week 24; Week 48; Week 96
Determining DOR, DTG and M9 trough plasma concentration thresholds predictive of virological response
DOR, DTG and M9 trough plasma concentration in samples taken pre-dose
Time frame: Week 4; Week 24; Week 48; Week 96
Assessment of the effect of antiretroviral drugs trough plasma concentration on safety endpoints
DOR, DTG and M9 trough plasma concentration in samples taken pre-dose
Time frame: Week 4; Week 24; Week 48; Week 96
Changes in CD4 cell count, CD4 percentage, CD8 cell count, CD8 percentage, CD4/CD8 ratio
Change from baseline in CD4 cell count, CD4 percentage, CD8 cell count, CD8 percentage, CD4/CD8 ratio
Time frame: Week 48; Week 96
Adherence to ART
Adherence to ART by (1) pill count (considering a pill count adherence ratio \<95% as sub-optimal adherence), (2) 4-days and 1-month recall questions at every trial visit, (3) by TFV-DP quantification in dried blood spots (LC/MS). ARV pill burden will also be an endpoint in order to study the relation between adherence and ARV pill burden.
Time frame: Week 48; Week 96
Description of the distribution of CYP3A5/4 mutations according to ARV regimen
Type and frequency of alleles variants in the gene coding for CYP3A5/4
Time frame: Study long
Assessment of the impact of CYP3A5/4 mutations on PK
Impact of CYP3A5/4 mutations on pharmacokinetics of DOR, DTG and M9
Time frame: Study long
Assessment of the impact of CYP3A5/4 mutations on virological response and side effects
Virological response and side-effects depending on CYP3A5/4 mutations
Time frame: Study long
Explore additional polymorphism (i.e. UGT1A1) according to literature update
Assess additional polymorphism of UGT1A1
Time frame: Baseline
Cost-effectiveness and budget impact of using DOR-based versus DTG-based antiretroviral regimens
Cost-effectiveness measured by (1) Incremental health benefits of using one regimen compared to the other (in DALYs and QALYs), (2) Incremental economic costs of using one regimen compared to the other (USD), (3) Budget impact of changing from one regimen to the other (USD)
Time frame: Study long
Changes in truncal fat distribution in a sub-group of cisgender women enrolled in the trial
Change from baseline in truncal fat distribution. Truncal fat repartition will be measured by the proportion of fat tissue using DEXA-scanner assessment
Time frame: Week 48; Week 96
Changes in adipose tissue markers and immune activation markers in a sub-group of cisgender women enrolled in the trial
Change from baseline in adipose tissue markers (adiponectin, leptin) and immune activation markers (sCD14, sCD163). Measurement will be made on stored serum samples by immunonephelometry or ELISA.
Time frame: Week 48; Week 96
Changes in fat quality in a sub-group of cisgender women enrolled in the trial
Change from baseline (by abdominal subcutaneous surgical biopsy) in fat pathology, gene expression and global transcriptome analysis (RT-PCR and RNAseq). Measurement will be made on an abdominal fat tissue biopsy sample fixed for immunohistochemistry (Red Sirius, collagen 6, fibronectine, TFG-beta, alpha-SMA) and frozen for gene expression analysis by RT-PCR of markers of adipogenesis (PPARG, CEPBA), beiging (PRDM16, PGC1A), lipogenesis (FAS), adipocyte function (GLUT4), fibrosis (COL4, COL6, FN, TGFB, LOX, ASMA) and mDNA level (mDNA gene and nDNA).
Time frame: Week 48
Plan to share: Undecided
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Studies of the drugs tested here: Doravirine · Tenofovir · Lamivudine
ANRS, Emerging Infectious Diseases →