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.: PACTR201205000384379 Date of Approval: 24/05/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title FATI-01
Official scientific title A Prospective, Multicenter, Open, Randomized Phase 2a Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA <50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen After 24 Weeks of Treatment in ART naïve, Non Subtype B HIV-1 Infected Individuals From Tanzania and Ivory Coast
Brief summary describing the background and objectives of the trial A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained virological suppression defined as HIV-RNA <50 copies/ml of 3 different doses of Fozivudine in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of treatment in ART naïve, non subtype B HIV-1 infected individuals from Tanzania and Ivory Coast. The primary objective is to confirm a sustained virological suppression (HIV RNA <50 copies/ml) after 24 weeks of treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FATI 01
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 01/08/2012
Actual trial start date 07/01/2013
Anticipated date of last follow up 30/06/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Completed
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 Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fozivudine (FZD) / Lamivudine (3TC) / Efavirenz (EFV) FZD OD / 3TC OD / EFV OD 24 weeks FZD 3 tablets (600mg) BID / 3TC 1 tablet (300mg) OD or 2 tablets (150mg) OD / EFV 1 capsule (600mg) OD for the duration of 24 weeks 30
Experimental Group Fozivudine (FZD) / Lamivudine (3TC) / Efavirenz (EFV) FZD OD / 3TC OD / EFV OD 24 weeks FZD 4 tablets (800mg) OD / 3TC 1 tablet (300mg) OD or 2 tablets (150mg) OD / EFV 1 capsule (600mg) OD for the duration of 24 weeks 30
Experimental Group Fozivudine (FZD) / Lamivudine (3TC) / Efavirenz (EFV) FZD OD / 3TC OD / EFV OD 24 weeks FZD 6 tablets (1200mg) OD / 3TC 1 tablet (300mg) OD or 2 tablets (150mg) OD / EFV 1 capsule (600mg) OD for the duration of 24 weeks 30
Control Group Zidovudine (AZT) / Lamivudine (3TC) / Efavirenz (EFV) AZT BID / 3TC BID / EFV OD 24 weeks 1 tablet (AZT 300mg/3TC 150mg) BID / EFV 1 capsule OD for the duration of 24 weeks 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male or female ¿ 18 years of age. 2. Provide written or thump printed informed consent prior to all trial-related procedures 3. HIV-1 positive with an indication to start antiretroviral therapy (ART) according to WHO and/or country guidelines 4. ART naïve, including no history of antiretroviral medication during PMTCT or PEP 5. Patient agrees not to take any concomitant medication during the trial without informing the investigator. Traditional medicines should be specified with concomitant medications. 6. Availability throughout the study 7. Female patients of childbearing potential must have a negative pregnancy test and agree to use a highly effective method of birth control throughout participation in the trial and for 10 weeks after last dose (to cover duration of ovulation). 8. Agree to have home visits or active tracing if lost to follow up or any other event justifying a rapid visit of the patient at the clinical trial centre. 9. CD4 count ¿100 cells/¿l 10. Hb ¿9.5 g/dl 11. Platelets ¿50,000 cells/mm3 12. Neutrophils ¿500 cells/ mm3 13. Bilirubin <2.5 x uln 14. ALT <2.5 x uln 15. Exclusion of Severe hepatic insufficiency (PT<50%) 16. Creatinine clearance calculated by Cockroft¿s formula ¿50 ml/min 17. Urine dipstick for protein and blood: negative or trace 1. Deficiency in the patient, rendering it difficult, if not impossible, for him/her to take part in the trial or understand the information provided to him/her 2. Presence of an uncontrolled, ongoing, opportunistic infection or of any severe or progressive disease including active TB or any other justified reason which in the opinion of the investigator could significantly inhibit study procedures. This includes any clinical signs possibly associated with any WHO stage 3 or 4, with still unconfirmed diagnosis such as fever, weight loss, diarrhoea or unexplained cough. 3. HIV-2 infection 4. Pregnancy or lactating mother 5. Unlikely to comply with protocol as judged by the principal investigator or his designate 6. Use of experimental therapeutic agents within 30 days of study entry. 7. Hepatitis B with positive HBsAg. 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 01/06/2012 Institutional Ethics review board of Munich University
Ethics Committee Address
Street address City Postal code Country
Pettenkoferstr. 8 Munich 80336 Germany
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 23/07/2012 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
n/a Dar es Salaam n/a Tanzania
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 30/03/2012 Comite National D'Ethique Et De La Recherche (CNER)
Ethics Committee Address
Street address City Postal code Country
n/a Abidjan n/a Cote Divoire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients with plasma HIV RNA < 50 copies/ml week 24
Secondary Outcome Proportion of patients with plasma HIV RNA <50 copies/ml week 8 week 12
Secondary Outcome Proportion of patients with plasma HIV RNA < 400 copies/ml week 8 week 12 week 24
Secondary Outcome Mean HIV log10 reduction compared to baseline week 2 week 4 week 8
Secondary Outcome Incidence of resistance mutations after confirmed treatment failure (confirmed HIV RNA >1000 copies/ml) Entire study period
Secondary Outcome Variation of circulating total lymphocyte count Entire study period
Secondary Outcome Variation of circulating CD4+ lymphocyte count Entire study period
Secondary Outcome Pharmacokinetic parameters after the first dose day 1 at steady state week 4
Secondary Outcome Proportion of clinical events stage 3 or 4 of WHO HIV classification ntire study period
Secondary Outcome Collection, analysis and if applicable reporting of Adverse Events Entire study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Service des Maladies Infectieuses et Tropicales, CHU de Treichville BPV3 Abidjan Abidjan Cote Divoire
NIMR - Mbeya Medical Research Center Hospital Hill, PO Box 2410 Mbeya Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership (EDCTP) Laan van Nieuw Oost Indië 334 The Hague Netherlands
German Federal Ministry of Education and Research Hannoversche Straße 28-30 Berlin 10115 Germany
French National Agency of Research On Aids and Viral Hepatitis (ANRS) 101 rue Tolbiac Paris 75013 France
EDCTP Laan van Nieuw Oost Indië 334 The Hague 2509 AA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor French National Agency of Research On Aids and Viral Hepatitis (ANRS) 101 rue Tolbiac, Paris 75013 France Charities/Societies/Foundation
Primary Sponsor Klinikum der Universität München, Prof. Dr. med. Burkhard Göke Marchioninistr. 15 Munich 81377 Germany University
COLLABORATORS
Name Street address City Postal code Country
Prof. Jean-François Delfraissy, Agence Nationale de Recherches sur le Sida et les hépatites virales (ANRS) 101, rue de Tolbiac Paris 75013 France
Dr. Betty Norman, Ministry of Health through the Komfo Anokye Teaching Hospital P.O.Box 1934 Kumasi Ghana
Dr. Lucas Maganga, NIMR - Mbeya Medical Research Programme Hospital Hill, PO Box 2410, Mbeya Tanzania
Prof. Michael Hoelscher , Klinikum of the University of Munich Leopoldstr. 5 Munich 80799 Germany
Dr. Arne Kroidl, Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich Leopoldstr. 5 Munich 80799 Germany
Dr. Serge Paul Eholié, Service des Maladies Infectieuses et Tropicales, CHU de Treichville BPV3 Abidjan Abidjan Cote Divoire
Dr. Leonard Maboko, NIMR - Mbeya Medical Research Programme, Hospital Hill Mbeya PO Box 2410 Tanzania
Dr. Torsten Feldt, Bernhard-Nocht-Institute for Tropical Medicine, Bernhard-Nocht.Str. 74 Hamburg 20359 Germany
Dr. Ralf Zuhse, Chiracon GmbH Biotechnology park Luckenwalde 14943 Germany
Mr. Yan-Ho Choo, STADA Vietnam Joint Venture Company Ltd. 40 Tu Do Avenue, Vietnam Singapore Industrial Park Binh Duong Viet Nam
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Hoelscher hoelscher@lrz.uni-muenchen.de +49 89 2180 17601 Leopoldstr. 5
City Postal code Country Position/Affiliation
Munich 80799 Germany Chief Investigator
Role Name Email Phone Street address
Public Enquiries Otto Geisenberger geisenberger@lrz.uni-muenchen.de +49 89 2180 17626 Leopoldstr. 5
City Postal code Country Position/Affiliation
Munich 80799 Germany Project Management
Role Name Email Phone Street address
Public Enquiries Ulrich Braun braun@lrz.uni-muenchen.de +49 89 2180 17621 Georgenstr. 5
City Postal code Country Position/Affiliation
Munich 80799 Germany Project Management
Role Name Email Phone Street address
Scientific Enquiries Arne Kroidl akroidl@mmrp.org +49 89 2180 17616 Leopoldstr. 5
City Postal code Country Position/Affiliation
Munich 80799 Germany Coordinating Investigator, Project Leader, Medical Monitor
REPORTING
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Result URL Hyperlinks
Changes to trial information