At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 610 target
Drug / intervention
Doravirine + tenofovir DF + lamivudine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓HIV-1 positive confirmed by national testing strategies
- ✓Plasma HIV-1 RNA ≥1000 copies/mL within 30 days prior to randomization
- ✓Treatment indication based on physician assessment per local guidelines
- ✓Naïve to antiretroviral therapy including investigational agents
Key exclusion· 15
- ✕Ongoing pulmonary or extra-pulmonary tuberculosis
- ✕HIV-2 infection or HIV-1/HIV-2 co-infection
- ✕Prior cabotegravir long-acting or dapivirine PrEP
- ✕Oral PrEP or PEP within past 3 months, or no recent negative HIV-1 serology
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Open-label, Randomized, Multicenter Trial EvaLuating the Non-inferiority of DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
In Brief
A Phase 3 clinical trial evaluating Doravirine + tenofovir DF + lamivudine and Dolutegravir + tenofovir DF + lamivudine or emtricitabine for HIV-1-infection. Currently recruiting, targeting 610 participants across 19 sites in 6 countries.
Signals
Enrolling ahead of pace
Detailed Summary
Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesBrazil, Cameroon, Côte d’Ivoire, France, Mozambique, Thailand
Timeline
Phase 3Recruiting
2024202520262027
First PostedJan 2024
Enrollment StartJan 2025
TodayJul 2026
Primary CompletionNov 2026
Study CompletionNov 2027
First PostedJan 12, 2024
Enrollment StartJan 27, 2025
Primary CompletionNov 1, 2026
Study CompletionNov 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 2.5 years agoPrimary completion in 4 months
Interventions
Doravirine + tenofovir DF + lamivudinedrug
Oral administration
Dolutegravir + tenofovir DF + lamivudine or emtricitabinedrug
Oral administration