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

NCT01709084 | Completed Phase 3 Results DMC

• 2 other identifiers: CR100875TMC278IFD3002
• Study Type: interventional
• Target: 426
• Locations: 6 countries
• Sites: 18

Brief Summary

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).

Conditions

Human Immunodeficiency Virus-type 1 Infection

Keywords

Human immunodeficiency virus-type 1 infection; HIV-1; Infectious diseases; Ribonucleic acid; RNA; Tenofovir disoproxil fumarate; Emtricitabine; Rilpivirine; Efavirenz; Edurant; TMC278; R278474; Fixed dose combination

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48

  Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.

  Week 48

Secondary Outcomes (5)

• Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48

  Week 48

• Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.

  Week 48

• Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.

  Week 48

• Percentage of Participant With Treatment Adherence Based on Tablet Count

  Up to 48 Weeks

• Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations

  Up to Week 48

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Rilpivirine; Drug: Tenofovir disoproxil fumarate; Drug: Emtricitabine

Group 2

ACTIVE COMPARATOR

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

Drug: Efavirenz; Drug: Tenofovir disoproxil fumarate; Drug: Emtricitabine

Interventions

Rilpivirine 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.

Also known as: EDURANT

Group 1

Efavirenz 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.

Group 2

Tenofovir disoproxil fumarate 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.

Group 1; Group 2

Emtricitabine 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 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (18)

Unknown Facility

Douala, Cameroon

Location

Unknown Facility

Yaoundé, Cameroon

Location

Unknown Facility

Eldoret, Kenya

Location

Unknown Facility

Kangemi, Nairobi, Kenya

Location

Unknown Facility

Nairobi, Kenya

Location

Unknown Facility

Nyanza, Kenya

Location

Unknown Facility

Dakar, Senegal

Location

Unknown Facility

Pikine, Senegal

Location

Unknown Facility

Bloemfontein, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Soweto, South Africa

Location

Unknown Facility

Wentworth, Durban, South Africa

Location

Unknown Facility

Westville, KwaZulu, South Africa

Location

Unknown Facility

Amphur Mueang Nonthaburi, Thailand

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Unknown Facility

Entebbe, Uganda

Location

Unknown Facility

Kampala, Uganda

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Rilpivirine; efavirenz; Tenofovir; Emtricitabine

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

It was an open label switch study with a significant number of patients (55%) on the Efavirenz (EFV) arm who did not switch their Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) unlike in the Rilpivirine (RPV) arm where 100% switched.

Results Point of Contact

• Title: Director, R&D, Medical Departement
• Organization: Janssen R&D US

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 17, 2012
• Study Start: October 2, 2013
• Primary Completion: October 22, 2015
• Study Completion: July 2, 2020
• Last Updated: February 11, 2021
• Results First Posted: January 5, 2017

Record last verified: 2021-01

Locations

SE (2); TH (3); CA (2); ZA (5); UG (2); KE (4)