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

NCT02777229 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2021-08-31

No results posted yet for this study

Summary

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

Interventions

DRUG

Dolutegravir 50 mg

1 tablet once a day

DRUG

Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg

Fixed dose combination, 1 tablet once a day

DRUG

Efavirenz 400 mg

1 tablets once a day

Sponsors & Collaborators

  • Institut de Recherche pour le Developpement

    collaborator OTHER_GOV

  • UNITAID

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Eric Delaporte, MD, PhD · IRD, INSERM, University Montpellier

  • Charles Kouanfack, MD, PhD · Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-07-31
Completion
2021-07-31

Countries

  • Cameroon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777229 on ClinicalTrials.gov