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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

616 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dolutegravir

Dolutegravir 50 mg Quaque die (QD) + tenofovir disoproxil fumarate/lamivudine 300 mg/ 300 mg Fixed Dose Combination (FDC) QD

Group Type EXPERIMENTAL

Dolutegravir 50 mg

Intervention Type DRUG

1 tablet once a day

Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg

Intervention Type DRUG

Fixed dose combination, 1 tablet once a day

Efavirenz

Efavirenz 400 mg QD + tenofovir disoproxil fumarate/lamivudine 300 mg/ 300 mg FDC QD

Group Type ACTIVE_COMPARATOR

Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg

Intervention Type DRUG

Fixed dose combination, 1 tablet once a day

Efavirenz 400 mg

Intervention Type DRUG

1 tablets once a day

Interventions

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Dolutegravir 50 mg

1 tablet once a day

Intervention Type DRUG

Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg

Fixed dose combination, 1 tablet once a day

Intervention Type DRUG

Efavirenz 400 mg

1 tablets once a day

Intervention Type DRUG

Other Intervention Names

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DTG TDF / 3TC EFV400

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No