Several reports indicate that treatment failure due to HIV resistance or to adverse event-related discontinuation could compromise the effectiveness of scaling-up antiretroviral treatment (ART), especially when lack of access to viral load is a concern. Combined with other nucleoside reverse transcriptase inhibitor, Dolutegravir (DTG) is a very promising alternative to the current first-line non nucleoside reverse transcriptase inhibitor-based regimens. Initial evaluations of DTG conducted in high income countries showed excellent efficacy and safety and indicated high genetic barrier thus preserving second line treatment. As a consequence, DTG-based regimens have been recently included in the first-line options in the national guidelines for ART of several high-income countries. However, the clinical trials evaluating DTG-based regimens have been conducted in highly controlled conditions, including baseline resistance testing and regular viral load monitoring. Moreover, these trials included a high proportion of men with rare co-morbidities. There is need to evaluate how a DTG-based regimen will perform in real-world conditions within resources-constrained settings, where viral load monitoring is limited, and where the majority of HIV patients are women with important family planning consideration and NAMSAL trial is a randomized clinical trial which aims to evaluate efficacy and safety over 48, 96 and 192 weeks of DTG + tenofovir disoproxil fumarate/lamivudine versus Efavirenz (EFV) + tenofovir disoproxil fumarate/lamivudine in 606 ART-naïve HIV-1-infected adults in Cameroon. A set of efficacy and safety endpoints will be compared over 48, 96 and 192 weeks between the two arms including the proportion of patients with viral load \<50 copies/mL and incidence of severe adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
616
1 tablet once a day
Fixed dose combination, 1 tablet once a day
1 tablets once a day
Cité verte Hospital
Yaoundé, Cameroon
Hopital Central
Yaoundé, Cameroon
Military Hospital
Yaoundé, Cameroon
Proportion of patients with Viral Load (VL) <50 cp/mL
Proportion of patients with Viral Load (VL) \<50 cp/mL at week 48 (FDA snapshot algorithm)
Time frame: week 48
Proportion of patients with Viral Load (VL) <50 cp/mL
Proportion of patients with Viral Load (VL) \<50 cp/mL at week 96 (FDA snapshot algorithm)
Time frame: week 96
Proportion of patients with Viral Load (VL) <50 cp/mL
Proportion of patients with VL\< 50 cp/mL at week 24 (FDA snapshot algorithm)
Time frame: week 24
Proportion of patients with Viral Load (VL) < 200 cp/mL
Proportion of patients with VL\< 200 cp/mL (FDA snapshot algorithm)
Time frame: week 24, week 48, week 96, week 144, week 192
Time to virologic failure
Time to virologic failure
Time frame: week 48, week 96, week 144, week 192
Changes in Cluster of differentiation 4 (CD4)-cell count from baseline to endpoints week-48, -96, -144, -192
Changes in Cluster of differentiation 4 (CD4)-cell count from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Time to death or to disease progression
Time to death or to disease progression
Time frame: week 48, week 96, week 144, week 192
Time to first toxicity failure
Time to first toxicity failure
Time frame: week 48, week 96, week 144, week 192
Incidence of first grade 3 or 4 clinical adverse event
Incidence of first grade 3 or 4 clinical adverse event
Time frame: week 48, week 96, week 144, week 192
Incidence of first grade 3 or 4 laboratory adverse event
Incidence of first grade 3 or 4 laboratory adverse event
Time frame: week 48, week 96, week 144, week 192
AE and SAE
Incidence of adverse events (AE) and serious adverse event (SAE)
Time frame: week 48, week 96, week 144, week 192
Time to treatment discontinuation
Time to treatment discontinuation
Time frame: week 48, week 96, week 144, week 192
Hemoglobine changes from baseline to endpoints week-48, -96, -144, -192
Changes in hemoglobin Time to virologic failure from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in creatinine from baseline to endpoints week-48, -96, -144, -192
Changes in creatinine from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in estimated glomerular filtration rate from baseline to endpoints week-48, -96, -144, -192
Changes in estimated glomerular filtration rate from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in Aspartate Aminotransferase (AST) ffrom baseline to endpoints week-48, -96, -144, -192
Changes in Aspartate Aminotransferase (AST) from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in Alanine Aminotransferase (ALT) from baseline to endpoints week-48, -96, -144, -192
Changes in Alanine Aminotransferase (ALT) from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in level of fasting glucose from baseline to endpoints week-48, -96, -144, -192
Changes in level of fasting glucose from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in level of total cholesterol from baseline to endpoints week-48, -96, -144, -192
Changes in level of total cholesterol from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in level of triglycerides from baseline to endpoints week-48, -96, -144, -192
Changes in level of triglycerides from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Changes in level of HDL from baseline to endpoints week-48, -96, -144, -192
Changes in level of HDL from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96, week 144, week 192
Proportion of patients defaulting clinic schedule
Proportion of patients defaulting clinic schedule
Time frame: week 48, week 96, week 144, week 192
Mean medication adherence level from baseline to endpoints week-48, -96, -144, -192
Mean medication adherence level from baseline to endpoints week-48, -96, -144, -192
Time frame: week 48, week 96, week 144, week 192
Mean change in Depression Anxiety Stress Scale from baseline to endpoints week-48, -96, -144, -192
Mean change in Depression Anxiety Stress Scale from baseline to endpoints week-48, -96, -144, -192 * Depression Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe +28 * Anxiety Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe +20 * Stress Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe +34
Time frame: Baseline, week 48, week 96, week 144, week 192
Mean change in Quality of life score assessed by the Short Form health survey from baseline to endpoints week-48, -96, -144, -192
Mean change in Quality of life score assessed by the Short Form health survey from baseline to endpoints week-48, -96, -144, -192 (Score varies according to the items, in order to test the vigilance of the patient. Reading the results provides a semantic appreciation)
Time frame: Baseline, week 48, week 96, week 144, week 192
Mean change in EFV-related symptoms questionnaire score from baseline to endpoints week-48, -96, -144, -192
Mean change in EFV-related symptoms questionnaire score from baseline to endpoints week-48, -96, -144, -192
Time frame: Baseline, week 48, week 96
Tobacco status consumtion
The status of tobacco smoker / non-smoker will be requested.
Time frame: week 192
HbA1c
Levels of glycated hemoglobin
Time frame: week 192
hsPCR
Levels of high sensitivity protein C reactive
Time frame: week 192
Lipodistrophia
Qualitative and quantitative measurements of soft tissue composition = Lipodistrophia
Time frame: week 192
CIMT
Mesures of Carotid Intima-Media Thickness
Time frame: week 192
PWV
Mesures of Pulse Wave Velocity
Time frame: week 192
Levels of adiponectin
Levels of adiponectin
Time frame: Baseline, week 48, week 96, week 144, week 192
Levels of leptin
Levels of leptin
Time frame: Baseline, week 48, week 96, week 144, week 192
Levels of ghrelin
Levels of ghrelin
Time frame: Baseline, week 48, week 96, week 144, week 192
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