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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: www.pactr.org

Trial no.: PACTR201210000439384 Date registered: 2012/10/19
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 HIV/AIDS ,
Purpose of the trial Treatment
Anticipated trial start date 2013-04-01
Actual trial start date
Anticipated date of last follow up 2015-08-15
Actual date of last follow up
Anticipated target sample size (number of participants) 426   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
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
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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 99 Years 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 2012/10/26 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

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
Makerere University -Walter Reed Project Plot 42, Nakasero Road Kampala Uganda
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

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 Company

COLLABORATORS
Name Street address City Postal code Country
not applicable

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Mrs S. Armstrong sherry@crafrica.com +254 (0)702 707 764
Street address City Postal code Country Position / Affiliation
PO Box 422 Karen 00502 Kenya Managing Director
Role Name Email Phone Fax
Scientific Enquiries Dr P Mohammed pmohamme@its.jnj.com +44 7770821396
Street address City Postal code Country Position / Affiliation
United Kingdom Study Responsible Physician