NCT04880395

Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Fundación Huésped · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Intervention Arm: dolutegravir/lamivudine	1 pill QD
DRUG	Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)	1 pill of each QD

Timeline

• Start date: 2021-05-17
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2021-05-10
• Last updated: 2025-07-30
• Results posted: 2025-07-30

Locations

11 sites across 2 countries: Argentina, Brazil