Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.
Be at least 18 years of age on the day of signing the informed consent.
Be HIV-1 positive as determined according to national testing strategies
Have a plasma HIV-1 RNA ≥1000 copies/mL within 30 days prior to the randomization,
Have HIV treatment indication based on physician assessment according to local treatment guidelines
None
Parallel
Doravirine + tenofovir DF + lamivudine
DrugOral administration
Dolutegravir + tenofovir DF + lamivudine or emtricitabine
DrugOral 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.
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.
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
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.
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
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ANRS, Emerging Infectious Diseases
Lead sponsor
MSD France
Collaborator
European and Developing Countries Clinical Trials Partnership (EDCTP)
Collaborator