Trial record 12 of 41 for:    " September 19, 2012":" October 19, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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 (SALIF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen-Cilag International NV
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01709084
First received: October 16, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Human Immunodeficiency Virus-type 1 Infection
Drug: Rilpivirine
Drug: Efavirenz
Drug: Tenofovir disoproxil fumarate
Drug: Emtricitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression <400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients. Switching At Low HIV-1 RNA Into Fixed Dose Combinations (SALIF)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • Number of patients with plasma HIV-1 RNA levels less than 400 copies per mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Number of patients with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL.


Secondary Outcome Measures:
  • Number of patients with plasma HIV-1 RNA levels less than 50 copies per mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of patients with plasma HIV-1 RNA levels more than or equal to 400 copies per mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of patients with plasma HIV-1 RNA levels more than or equal to 50 copies per mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of patients with treatment-emergent nucleoside reverse transcriptase inhibitor (N[t]RTI) or nucleoside/nucleotide reverse transcriptase inhibitor (NNRTI) mutations [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Number of adherent patients based on tablet count [ Time Frame: Up to Week 48 or study medication discontinuation ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Up to 30 to 35 days after administration of last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 426
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Patients will receive fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate/emtricitabine/rilpivirine with a meal, until Week 48.
Drug: 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.
Other Name: EDURANT
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.
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.
Active Comparator: Group 2
Patients will receive FDC tablet of tenofovir disoproxil fumarate/emtricitabine /efavirenz on an empty stomach at bedtime, until Week 48.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709084

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
Cameroon
Active, not recruiting
Douala, Cameroon
Withdrawn
Douala, Cameroon
Withdrawn
Yaounde, Cameroon
Active, not recruiting
Yaounde, Cameroon
Ghana
Not yet recruiting
Bolgatanga, Ghana
Withdrawn
Bolgatanga, Ghana
Withdrawn
Great Accra, Ghana
Not yet recruiting
Kumasi, Ghana
Withdrawn
Navarongo, Ghana
Not yet recruiting
Tamale, Ghana
Kenya
Recruiting
Eldoret, Kenya
Recruiting
Kangemi, Nairobi, Kenya
Withdrawn
Kisumu, Kenya
Recruiting
Nairobi, Kenya
Recruiting
Nyanza, Kenya
Senegal
Withdrawn
Dakar, Senegal
Recruiting
Dakar, Senegal
Withdrawn
Dakar Fann, Senegal
Recruiting
Pikine, Senegal
South Africa
Recruiting
Bloemfontein, South Africa
Withdrawn
Cape Town, South Africa
Withdrawn
East London, South Africa
Recruiting
Johannesburg, South Africa
Withdrawn
Port Elizabeth, South Africa
Recruiting
Soweto, South Africa
Recruiting
Wentworth, Durban, South Africa
Recruiting
Westville, Kwazulu, South Africa
Thailand
Recruiting
Amphur Mueang Nonthaburi, Thailand
Recruiting
Bangkok, Thailand
Recruiting
Chiang Mai, Thailand
Uganda
Withdrawn
Bushenyl, Uganda
Recruiting
Entebbe, Uganda
Withdrawn
Kampala, Uganda
Recruiting
Kampala, Uganda
Withdrawn
Masaka, Uganda
Withdrawn
Mbarara District, Uganda
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01709084     History of Changes
Other Study ID Numbers: CR100875, TMC278IFD3002
Study First Received: October 16, 2012
Last Updated: August 14, 2014
Health Authority: Cameroon: Ministry of Public Health
Ghana: Ministry of Health
Kenya: Ministry of Health
Senegal: Ministere de la sante
South Africa: Medicines Control Council
Uganda: National Drug Authority
Thailand: Ministry of Public Health
Vietnam: Ministry of Health

Keywords provided by Janssen-Cilag International NV:
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 28, 2014