Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201210000439384 Date of Approval: 19/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Study to Compare Efficacy in Terms of Plasma HIV-1 RNA Between 2 Fixed Dose Combinations After a Switch in Fully Suppressed Patients
Official scientific title Switching At Low HIV-1 RNA Into Fixed Dose Combinations
Brief summary describing the background and objectives of the trial 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 virustype 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).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SALIF
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2013
Actual trial start date 27/08/2013
Anticipated date of last follow up 29/10/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 426
Actual target sample size (number of participants) 426
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Subjects will be randomly assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule prepared before the study by or under the supervision of the sponsor. The randomization will be balanced by using randomly permuted blocks and will be stratified by the NNRTI the subject is taking at screening (either EFV or NVP). Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group EFV-FDC 1 tablet per day at least 48 weeks Patients will receive fixed dose combination (FDC) tablet of efavirenz / tenofovir disoproxil fumarate / emtricitabine 213 Active-Treatment of Control Group
Experimental Group RPV-FDC 1 tablet per day at least 48 weeks Patients will receive fixed dose combination (FDC) tablet of rilpivirine / tenofovir disoproxil fumarate / emtricitabine 213 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 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 prefer to change the current HAART regimen for reasons of simplification and/or due to toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI) - Antiretroviral (ARV) combination treatment for at least 8 weeks before the screening visit and expected to continue on the same regimen throughout the screening period - Plasma HIV-1 RNA less than 50 copies per mL and cluster of differentiation 4 positive (CD4+) cell count more than 200 per cubic millimeter - Agrees to protocol-defined use of effective contraception - History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than or equal to 400 copies per mL) and immunologic failure (2 consecutive CD4+ cell counts) while on previous or current ART - History of any primary N[t]RTI or NNRTI mutations below the pre HAART level - 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 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2012 Uganda Virus Research Institute SEC
Ethics Committee Address
Street address City Postal code Country
Plot 51-59, Nakiwogo Road Entebbe Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road, Ntinda Kampala P.O.Box 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/01/2013 Uganda Virus Research Institute (UVRI) Science and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
50-59 Nakiwogo Road Entebbe Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of pt with plasma HIV-1 less then 400 copies per mL week 48
Secondary Outcome Number of patients with plasma HIV-1 RNA levels less than 50 copies per mL week 48
Secondary Outcome Number of patients with plasma HIV-1 RNA levels more than or equal to 400 copies per mL week 48
Secondary Outcome Number of patients with plasma HIV-1 RNA levels more than or equal to 50 copies per mL week 48
Secondary Outcome Number of patients with treatment-emergent nucleoside reverse transcriptase inhibitor (N[t]RTI) or nucleoside/nucleotide reverse transcriptase inhibitor (NNRTI) mutations up to week 48
Secondary Outcome Number of adherent patients based on tablet count up to week 48 or medication discontinuation
Secondary Outcome Number of patients with adverse events Up to 30 to 35 days after administration of last dose of study medication
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Joint Clinical Research Centre- Kampala Plot 101 Lubowa Kampala Uganda
Makerere University Joint AIDS Program Plot 4B Kololo Hill Drive Kampala Uganda
MRC/UVRI Uganda Research on AIDS 50-59 Nakiwogo Road Entebbe Uganda
Infectious Diseases Institute, Mulago Hospital Complex Mulago Hill Road Kampala Uganda
Makerere University -Walter Reed Project Plot 42, Nakasero Road Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen-Cilag International NV Turnhoutseweg 30 Beerse B-2340 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen-Cilag International NV Turnhoutseweg 30 Beerse B-2340 Belgium Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
not applicable
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries S. Armstrong sherry@crafrica.com +254 (0)702 707 764 PO Box 422
City Postal code Country Position/Affiliation
Karen 00502 Kenya Managing Director
Role Name Email Phone Street address
Scientific Enquiries P Mohammed pmohamme@its.jnj.com +44 7770821396
City Postal code Country Position/Affiliation
United Kingdom Study Responsible Physician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information