Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-30 @ 8:37 PM
Study NCT ID:
NCT04880395
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Sponsor:
Fundación Huésped
Organization:
Study Overview
Official Title:
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOLCE
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: