Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT04880395
Brief 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.
Detailed Description:
Primary endpoint: Proportion of patients with viral load \< 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snapshot) for the intent-to-treat exposed (ITT-E) population.
Secondary Objectives:
* To assess the antiviral activity of DTG+3TC and DTG+TDF/XTC at week 24
* To evaluate the safety and tolerability of DTG+3TC and DTG+TDF/XTC over time
* To assess the antiviral activity of DTG+3TC and DTG+TDF/XTC at week 48 in patients with baseline viral load \>100,000 c/mL
* To evaluate immunological activity (CD4+ lymphocyte \[CD4 counts\]) at Week 24 and Week 48
* To assess the development of HIV-1 resistance in patients with virologic failure or viral rebound treated with DTG+3TC or DTG+TDF/XTC
* To evaluate the incidence of disease progression (HIV-associated conditions, AIDS and death) of DTG + 3TC and DTG + TDF/XTC over time.
Secondary endpoints:
* Proportion of patients treated with DTG+3TC and DTG+TDF/XTC with HIV-1 levels of less than 50 copies/mL at week 24
* Frequency, type and severity of adverse events and laboratory abnormalities and proportion of patients who discontinue DTG+3TC or DTG+TDF/XTC due to adverse events or death
* Proportion of patients with baseline HIV-1 RNA \>100,000 c/mL that achieve virological suppression at week 48 weeks,
* Changes in CD4 count, CD8 count and CD4/CD8 ratio between baseline and 48 weeks
* Number and type of resistance mutations in case of virologic failure (defined as a confirmed viral above 200 copies/mL after week 24 copies/mL or viral rebound at any timepoint)
* Incidence of IRIS and disease progression (HIV associated conditions, AIDS and death).
Tertiary objectives:
● TDF/XTCTo explore change in health-related quality-of-life for subjects treated with DTG plus 3TC and DTG + TDF/XTC
Tertiary endpoints:
● Change from Baseline in health-related quality of life using EQ-5D-5L and PHQ9 at Weeks 24, and 48
Patient Population:
HIV-1-infected subjects aged \>18 years who are naïve to antiretroviral therapy with ≤200 CD4 cell/mm3
Study Design:
Prospective, Phase IV, randomized, multicenter, parallel group study design
Regimens:
Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg.
Duration: 48 weeks
Sample size:230 subjects
Study:
NCT04880395
Study Brief:
Protocol Section:
NCT04880395