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

HIV-1-infection Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• HIV-1-infection

• NCT number: NCT04880395
• Study type: Interventional
• Source: Fundación Huésped
• Contact: María Inés Figueroa, MD
• Phone: 541149817777
• Email: maria.figueroa@huesped.org.ar
• Status: Recruiting
• Phase: Phase 4
• Start date: May 20, 2021
• Completion date: November 20, 2024