HIV-1 InfectionPhase 3NAMSALNCT02777229

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

A Phase 3 study testing Dolutegravir 50 mg, Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg and Efavirenz 400 mg in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 3 sites in Cameroon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: Dolutegravir 50 mg, Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg and Efavirenz 400 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 616 participants
Where: 3 sitesCameroon
Study dates: Jul 2016to Jul 2021
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 12Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

Cameroon3 sites

Cité verte Hospital
Yaoundé
Hopital Central
Yaoundé
Military Hospital
Yaoundé

Other trials in Cameroon

About this study

Official 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

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.

Conditions: HIV-1 Infection
Being tested: Dolutegravir 50 mg, Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg, Efavirenz 400 mg
Keywords: Dolutegravir, Efavirenz-low-dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dolutegravir 50 mgDrug
Also called DTG
1 tablet once a day
Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mgDrug
Also called TDF / 3TC
Fixed dose combination, 1 tablet once a day
Efavirenz 400 mgDrug
Also called EFV400
1 tablets once a day

Study groups in NCT02777229
Study group	Role	What they receive
Dolutegravir	Experimental	Dolutegravir 50 mg Quaque die (QD) + tenofovir disoproxil fumarate/lamivudine 300 mg/ 300 mg Fixed Dose Combination (FDC) QD Receives: Drug: Dolutegravir 50 mg; Drug: Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg
Efavirenz	Active comparator	Efavirenz 400 mg QD + tenofovir disoproxil fumarate/lamivudine 300 mg/ 300 mg FDC QD Receives: Drug: Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg; Drug: Efavirenz 400 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: week 48

Secondary outcomes (34)

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)
Measured: 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)
Measured: week 24
Proportion of patients with Viral Load (VL) < 200 cp/mL
Proportion of patients with VL< 200 cp/mL (FDA snapshot algorithm)
Measured: week 24, week 48, week 96, week 144, week 192
Time to virologic failure
Time to virologic failure
Measured: 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
Measured: Baseline, week 48, week 96, week 144, week 192
Time to death or to disease progression
Time to death or to disease progression
Measured: week 48, week 96, week 144, week 192
Time to first toxicity failure
Time to first toxicity failure
Measured: 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
Measured: 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
Measured: week 48, week 96, week 144, week 192
AE and SAE
Incidence of adverse events (AE) and serious adverse event (SAE)
Measured: week 48, week 96, week 144, week 192
Time to treatment discontinuation
Time to treatment discontinuation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, week 48, week 96, week 144, week 192
Proportion of patients defaulting clinic schedule
Proportion of patients defaulting clinic schedule
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline, week 48, week 96
Tobacco status consumtion
The status of tobacco smoker / non-smoker will be requested.
Measured: week 192
HbA1c
Levels of glycated hemoglobin
Measured: week 192
hsPCR
Levels of high sensitivity protein C reactive
Measured: week 192
Lipodistrophia
Qualitative and quantitative measurements of soft tissue composition = Lipodistrophia
Measured: week 192
CIMT
Mesures of Carotid Intima-Media Thickness
Measured: week 192
PWV
Mesures of Pulse Wave Velocity
Measured: week 192
Levels of adiponectin
Levels of adiponectin
Measured: Baseline, week 48, week 96, week 144, week 192
Levels of leptin
Levels of leptin
Measured: Baseline, week 48, week 96, week 144, week 192
Levels of ghrelin
Levels of ghrelin
Measured: Baseline, week 48, week 96, week 144, week 192

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Jul 2021

First posted19 May 2016 (estimated)
Study startJul 2016
Primary completionJul 2018
Study completionJul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 616 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02777229
Sponsor's protocol ID: ANRS 12313 NAMSAL
Acronym: NAMSAL
Status last verified: Feb 2021
First submitted: 1 Mar 2016
Last updated: 31 Aug 2021
Results posted: No
Data monitoring committee: Yes

Publications

Mpoudi-Etame M, Tovar Sanchez T, Bousmah MA, Omgba Bassega P, Olinga J, Mimbe E, Foalem M, Chiep C, Edimo S, Varloteaux M, Pelloquin R, Lamare N, Boyer S, Peeters M, Reynes J, Calmy A, Hill A, Delaporte E, Kouanfack C; New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-income countries (NAMSAL-ANRS-12313) study group. Durability of the Efficacy and Safety of Dolutegravir-Based and Low-Dose Efavirenz-Based Regimens for the Initial Treatment of Human Immunodeficiency Virus Type 1 Infection in Cameroon: Week 192 Data of the NAMSAL-ANRS-12313 Study. Open Forum Infect Dis. 2023 Nov 20;10(12):ofad582. doi: 10.1093/ofid/ofad582. eCollection 2023 Dec.
PubMed 38156046
Bousmah MA, Protopopescu C, Mpoudi-Etame M, Omgba Bassega P, Maradan G, Olinga J, Varloteaux M, Tovar-Sanchez T, Delaporte E, Kouanfack C, Boyer S; NAMSAL ANRS 12313 Study Group. Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial). J Acquir Immune Defic Syndr. 2023 Nov 1;94(3):262-272. doi: 10.1097/QAI.0000000000003273.
PubMed 37851566
Bousmah MA, Nishimwe ML, Tovar-Sanchez T, Lantche Wandji M, Mpoudi-Etame M, Maradan G, Omgba Bassega P, Varloteaux M, Montoyo A, Kouanfack C, Delaporte E, Boyer S; New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-Income Countries (NAMSAL) ANRS 12313 Study Group. Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial). Pharmacoeconomics. 2021 Mar;39(3):331-343. doi: 10.1007/s40273-020-00987-3. Epub 2020 Dec 23.
PubMed 33355914
Calmy A, Tovar Sanchez T, Kouanfack C, Mpoudi-Etame M, Leroy S, Perrineau S, Lantche Wandji M, Tetsa Tata D, Omgba Bassega P, Abong Bwenda T, Varloteaux M, Tongo M, Mpoudi-Ngole E, Montoyo A, Mercier N, LeMoing V, Peeters M, Reynes J, Delaporte E; New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-Income Countries (NAMSAL) ANRS 12313 Study Group. Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon. Lancet HIV. 2020 Oct;7(10):e677-e687. doi: 10.1016/S2352-3018(20)30238-1.
PubMed 33010241
NAMSAL ANRS 12313 Study Group; Kouanfack C, Mpoudi-Etame M, Omgba Bassega P, Eymard-Duvernay S, Leroy S, Boyer S, Peeters M, Calmy A, Delaporte E. Dolutegravir-Based or Low-Dose Efavirenz-Based Regimen for the Treatment of HIV-1. N Engl J Med. 2019 Aug 29;381(9):816-826. doi: 10.1056/NEJMoa1904340. Epub 2019 Jul 24.
PubMed 31339676

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02777229
Acronym / sponsor ID: NAMSAL / ANRS 12313 NAMSAL
Conditions: HIV-1 Infection
Keywords: Dolutegravir, Efavirenz-low-dose
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 616 participants (actual)
Lead sponsor: ANRS, Emerging Infectious DiseasesOther government
Collaborators: Institut de Recherche pour le Developpement, UNITAID
Study start: Jul 2016 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2021 (actual)
First posted: 19 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dolutegravir	Experimental	Drug: Dolutegravir 50 mg, Drug: Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mgDolutegravir 50 mg Quaque die (QD) + tenofovir disoproxil fumarate/lamivudine 300 mg/ 300 mg Fixed Dose Combination (FDC) QD
Efavirenz	Active comparator	Drug: Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg, Drug: Efavirenz 400 mgEfavirenz 400 mg QD + tenofovir disoproxil fumarate/lamivudine 300 mg/ 300 mg FDC QD

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dolutegravir 50 mgAlso: DTG1 tablet once a day	Drug	Dolutegravir
Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mgAlso: TDF / 3TCFixed dose combination, 1 tablet once a day	Drug	Dolutegravir, Efavirenz
Efavirenz 400 mgAlso: EFV4001 tablets once a day	Drug	Efavirenz

Primary outcome

Proportion of patients with Viral Load (VL) <50 cp/mL
Time frame: week 48
Proportion of patients with Viral Load (VL) <50 cp/mL at week 48 (FDA snapshot algorithm)

34 secondary outcomes

Proportion of patients with Viral Load (VL) <50 cp/mL
Time frame: week 96
Proportion of patients with Viral Load (VL) <50 cp/mL
Time frame: week 24
Proportion of patients with Viral Load (VL) < 200 cp/mL
Time frame: week 24, week 48, week 96, week 144, week 192
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
Time frame: Baseline, week 48, week 96, week 144, week 192
Time to death or to disease progression
Time frame: week 48, week 96, week 144, week 192
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
Time frame: 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
AE and SAE
Time frame: week 48, week 96, week 144, week 192
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
Time frame: Baseline, week 48, week 96, week 144, week 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
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
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
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
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 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
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
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
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
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
Time frame: week 192
HbA1c
Time frame: week 192
hsPCR
Time frame: week 192
Lipodistrophia
Time frame: week 192
CIMT
Time frame: week 192
PWV
Time frame: week 192
Levels of adiponectin
Time frame: Baseline, week 48, week 96, week 144, week 192
Levels of leptin
Time frame: Baseline, week 48, week 96, week 144, week 192
Levels of ghrelin
Time frame: Baseline, week 48, week 96, week 144, week 192

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
Derived from this study: PubMed 38156046Mpoudi-Etame M, Tovar Sanchez T, Bousmah MA, Omgba Bassega P, Olinga J, Mimbe E, Foalem M, Chiep C, Edimo S, Varloteaux M, Pelloquin R, Lamare N, Boyer S, Peeters M, Reynes J, Calmy A, Hill A, Delaporte E, Kouanfack C; New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-income countries (NAMSAL-ANRS-12313) study group. Durability of the Efficacy and Safety of Dolutegravir-Based and Low-Dose Efavirenz-Based Regimens for the Initial Treatment of Human Immunodeficiency Virus Type 1 Infection in Cameroon: Week 192 Data of the NAMSAL-ANRS-12313 Study. Open Forum Infect Dis. 2023 Nov 20;10(12):ofad582. doi: 10.1093/ofid/ofad582. eCollection 2023 Dec.
Derived from this study: PubMed 37851566Bousmah MA, Protopopescu C, Mpoudi-Etame M, Omgba Bassega P, Maradan G, Olinga J, Varloteaux M, Tovar-Sanchez T, Delaporte E, Kouanfack C, Boyer S; NAMSAL ANRS 12313 Study Group. Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial). J Acquir Immune Defic Syndr. 2023 Nov 1;94(3):262-272. doi: 10.1097/QAI.0000000000003273.
Derived from this study: PubMed 33355914Bousmah MA, Nishimwe ML, Tovar-Sanchez T, Lantche Wandji M, Mpoudi-Etame M, Maradan G, Omgba Bassega P, Varloteaux M, Montoyo A, Kouanfack C, Delaporte E, Boyer S; New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-Income Countries (NAMSAL) ANRS 12313 Study Group. Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial). Pharmacoeconomics. 2021 Mar;39(3):331-343. doi: 10.1007/s40273-020-00987-3. Epub 2020 Dec 23.
Derived from this study: PubMed 33010241Calmy A, Tovar Sanchez T, Kouanfack C, Mpoudi-Etame M, Leroy S, Perrineau S, Lantche Wandji M, Tetsa Tata D, Omgba Bassega P, Abong Bwenda T, Varloteaux M, Tongo M, Mpoudi-Ngole E, Montoyo A, Mercier N, LeMoing V, Peeters M, Reynes J, Delaporte E; New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-Income Countries (NAMSAL) ANRS 12313 Study Group. Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon. Lancet HIV. 2020 Oct;7(10):e677-e687. doi: 10.1016/S2352-3018(20)30238-1.
Derived from this study: PubMed 31339676NAMSAL ANRS 12313 Study Group; Kouanfack C, Mpoudi-Etame M, Omgba Bassega P, Eymard-Duvernay S, Leroy S, Boyer S, Peeters M, Calmy A, Delaporte E. Dolutegravir-Based or Low-Dose Efavirenz-Based Regimen for the Treatment of HIV-1. N Engl J Med. 2019 Aug 29;381(9):816-826. doi: 10.1056/NEJMoa1904340. Epub 2019 Jul 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric Delaporte, MD, PhD principal investigator

IRD, INSERM, University Montpellier

Charles Kouanfack, MD, PhD principal investigator

Central Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with Viral Load (VL) <50 cp/mL (time frame: week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02777229, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.