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A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment

NCT ID: NCT01709084

Last Updated: 2021-02-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-02

Study Completion Date

2020-07-02

Brief Summary

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The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).

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Detailed Description

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This is a 48-week, multicenter (study conducted at multiple sites), multinational (conducted at different countries), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to assess whether tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) shows noninferior response rates of human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) suppression less than 400 copies per mL, compared with TDF/FTC/efavirenz (TDF/FTC/EFV). The study consists of 3 phases including, the screening phase (of 6 weeks), treatment phase (of 48 weeks), and follow up phase (of 30 to 35 days after the last dose of study medication). During the 48 weeks treatment phase, patients currently with HIV-1 RNA suppression less than 50 copies per mL on their first-line antiretroviral regimen, will be randomized in a 1:1 ratio, in 2 groups, ie, Group 1 (treatment group) and Group 2 (control group). Both these groups will receive a fixed dose combination (FDC) regimen (ie, FDC tablet: one tablet per day) of either TDF/FTC/RPV in Group 1 or TDF/FTC/EFV in Group 2. Patients will return for study visits at Week 4, 12, 24, 36, and 48 during the treatment period, and then every 24 weeks thereafter during the extended treatment period until the last patient has his or her Week 48 (or treatment discontinuation) visit. Safety evaluations for adverse events, clinical laboratory (central and local) tests, electrocardiogram, vital signs, and physical examination will be performed throughout the study. The treatment duration for each patient will be expected to be between 48 and 108 weeks.

Conditions

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Human Immunodeficiency Virus-type 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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Group 1

Patients will receive fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate/emtricitabine/rilpivirine with a meal, until Week 48.

Group Type EXPERIMENTAL

Rilpivirine

Intervention Type DRUG

Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

Tenofovir disoproxil fumarate

Intervention Type DRUG

Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.

Emtricitabine

Intervention Type DRUG

Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.

Group 2

Patients will receive FDC tablet of tenofovir disoproxil fumarate/emtricitabine /efavirenz on an empty stomach at bedtime, until Week 48.

Group Type ACTIVE_COMPARATOR

Efavirenz

Intervention Type DRUG

Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

Tenofovir disoproxil fumarate

Intervention Type DRUG

Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.

Emtricitabine

Intervention Type DRUG

Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.

Interventions

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Rilpivirine

Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

Intervention Type DRUG

Efavirenz

Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

Intervention Type DRUG

Tenofovir disoproxil fumarate

Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.

Intervention Type DRUG

Emtricitabine

Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.

Intervention Type DRUG

Other Intervention Names

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EDURANT

Eligibility Criteria

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Inclusion Criteria

Documented human immunodeficiency virus-type 1 (HIV-1) infection Patients who have been receiving first line highly active antiretroviral therapy (HAART) for at least 1 year before the screening visit Patients who have been taking the same ARV combination for at least 8 weeks before the screening visit and are expected to continue on this regimen throughout the screening period.

Patients who prefer to change the current HAART regimen for reasons of simplification and/or toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N\[t\]RTI) Plasma HIV-1 RNA less than 50 copies per mL and CD4+ cell count higher than 200 per mm3 at the screening visit Agrees to protocol-defined use of effective contraception

Exclusion Criteria

History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than or equal to 400 copies per mL) while on previous or current ART History of immunologic failure (2 consecutive CD4+ cell counts during HAART treatment falling below the pre-HAART level) History of any primary N\[t\]RTI or NNRTI mutations Has a previously documented HIV-2 infection Significantly decreased hepatic function or hepatic insufficiency or diagnosed with acute clinical viral hepatitis Diagnosed with Mycobacterium tuberculosis infection Severe laboratory abnormalities Creatinine clearance less than 50 mL per minute Addicted to drug, including alcohol or recreational drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag International NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

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Douala, , Cameroon

Site Status

Yaoundé, , Cameroon

Site Status

Eldoret, , Kenya

Site Status

Kangemi, Nairobi, , Kenya

Site Status

Nairobi, , Kenya

Site Status

Nyanza, , Kenya

Site Status

Dakar, , Senegal

Site Status

Pikine, , Senegal

Site Status

Bloemfontein, , South Africa

Site Status

Johannesburg, , South Africa

Site Status

Soweto, , South Africa

Site Status

Wentworth, Durban, , South Africa

Site Status

Westville, KwaZulu, , South Africa

Site Status

Amphur Mueang Nonthaburi, , Thailand

Site Status

Bangkok, , Thailand

Site Status

Chiang Mai, , Thailand

Site Status

Entebbe, , Uganda

Site Status

Kampala, , Uganda

Site Status

Countries

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Cameroon Kenya Senegal South Africa Thailand Uganda

Other Identifiers

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TMC278IFD3002

Identifier Type: OTHER

Identifier Source: secondary_id

CR100875

Identifier Type: -

Identifier Source: org_study_id

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