At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 265 enrolled
Drug / intervention
Intervention Arm: dolutegravir/lamivudine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
In Brief
A Phase 4 clinical trial evaluating Intervention Arm: dolutegravir/lamivudine and Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) for HIV-1-infection. Completed, enrolled 265 participants across 11 sites in 2 countries.
Detailed Summary
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesArgentina, Brazil
CollaboratorsViiV Healthcare, Federal University of Bahia
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartMay 2021
Primary CompletionMay 2024
TodayJul 2026
First PostedMay 10, 2021
Enrollment StartMay 17, 2021
Primary CompletionMay 7, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.1 years ago
Interventions
Intervention Arm: dolutegravir/lamivudinedrug
1 pill QD
Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)drug
1 pill of each QD