Efficacy and Safety of a Dolutegravir-based Regimen for the Initial Management of HIV Infected Adults in Resource-limited Settings

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT02777229
• Date of registration: 01/03/2016
• Prospective Registration: Yes
• Primary sponsor: ANRS, Emerging Infectious Diseases
• Public title: Efficacy and Safety of a Dolutegravir-based Regimen for the Initial Management of HIV Infected Adults in Resource-limited Settings NAMSAL
• Scientific title: A Phase III Randomized, Open Label Trial to Evaluate Dolutegravir Versus Efavirenz 400 mg, Both Combined With Tenofovir Disoproxil Fumarate + Lamivudine for the Initial Management of HIV Infected Adults in Resource-limited Settings
• Date of first enrolment: July 2016
• Target sample size: 616
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02777229
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Cameroon

Contacts

• Name: Eric Delaporte, MD, PhD
• Affiliation: IRD, INSERM, University Montpellier

• Name: Charles Kouanfack, MD, PhD
• Affiliation: Central Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- HIV-1 infected

- Age = 18 years

- Abtiretroviral-naïve, including above 7 days of cumulative prior antiretroviral
therapy at any time prior to study entry.

- For women of childbearing potential: acceptance to use effective contraceptive methods

- Provision of written informed consent

Exclusion Criteria:

- Infection with HIV-1 group O, N, P

- Infection or co-infection with HIV-2

- Absolute neutrophil count (ANC) < 500 cells/mm3

- Hemoglobin < 7.0 g/dL

- Platelet count < 50,000 cells/mm3

- AST and/or ALT > 5 x Upper Limit of Normal (ULN)

- Calculated creatinine clearance < 50 mL/min

- Active opportunistic or severe disease not under adequate control

- For women of childbearing age : Pregnancy/breastfeeding

- History or presence of allergy and/or contraindications to the trial drugs or their
components

- Severe psychiatric illness

- Severe hepatic failure Patients co-infected with tuberculosis (TB), receiving a TB
treatment and with stable clinical condition will not be excluded.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV-1 Infection

Intervention(s)

Drug: Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg

Drug: Efavirenz 400 mg

Drug: Dolutegravir 50 mg

Primary Outcome(s)

Proportion of patients with Viral Load (VL) <50 cp/mL [Time Frame: week 48]

Secondary Outcome(s)

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 [Time Frame: Baseline, week 48, week 96, week 144, week 192]

Incidence of first grade 3 or 4 laboratory adverse event [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 [Time Frame: Baseline, week 48, week 96, week 144, week 192]

Incidence of first grade 3 or 4 clinical adverse event [Time Frame: week 48, week 96, week 144, week 192]

Lipodistrophia [Time Frame: week 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]

Changes in Aspartate Aminotransferase (AST) ffrom 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 [Time Frame: Baseline, week 48, week 96, week 144, week 192]

Proportion of patients defaulting clinic schedule [Time Frame: week 48, week 96, week 144, week 192]

Proportion of patients with Viral Load (VL) < 200 cp/mL [Time Frame: week 24, week 48, week 96, week 144, week 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]

CIMT [Time Frame: week 192]

Levels of adiponectin [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 [Time Frame: Baseline, 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 [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 [Time Frame: Baseline, week 48, week 96, week 144, week 192]

PWV [Time Frame: week 192]

Time to death or to disease progression [Time Frame: week 48, week 96, week 144, week 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]

Proportion of patients with Viral Load (VL) <50 cp/mL [Time Frame: week 24]

Time to first toxicity failure [Time Frame: week 48, week 96, week 144, week 192]

Levels of leptin [Time Frame: Baseline, week 48, week 96, week 144, week 192]

Mean medication adherence level from baseline to endpoints week-48, -96, -144, -192 [Time Frame: week 48, week 96, week 144, week 192]

hsPCR [Time Frame: week 192]

Proportion of patients with Viral Load (VL) <50 cp/mL [Time Frame: week 96]

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]

HbA1c [Time Frame: week 192]

Hemoglobine changes from baseline to endpoints week-48, -96, -144, -192 [Time Frame: Baseline, week 48, week 96, week 144, week 192]

Time to treatment discontinuation [Time Frame: week 48, week 96, week 144, week 192]

Tobacco status consumtion [Time Frame: week 192]

Levels of ghrelin [Time Frame: Baseline, week 48, week 96, week 144, week 192]

Time to virologic failure [Time Frame: week 48, week 96, week 144, week 192]

AE and SAE [Time Frame: week 48, week 96, week 144, week 192]

Secondary ID(s)

ANRS 12313 NAMSAL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UNITAID

Institut de Recherche pour le Developpement