FATI-01

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201205000384379
• Date of registration: 24/05/2012
• Prospective Registration: Yes
• Primary sponsor: Klinikum der Universität München, Prof. Dr. med. Burkhard Göke
• Public title: FATI-01
• 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
• Date of first enrolment: 01/08/2012
• Target sample size: 120
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=384
• Study type: Interventional
• Study design: 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
• Phase: Phase-2

Countries of recruitment

Cote Divoire, Tanzania

Contacts

• Name: Ulrich Braun
• Affiliation: Project Management

• Name: Otto Geisenberger
• Affiliation: Project Management

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: 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.

Age minimum: 18 Year(s)
Age maximum: 99 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS

HIV/AIDS

Intervention(s)

Fozivudine (FZD) / Lamivudine (3TC) / Efavirenz (EFV)

Zidovudine (AZT) / Lamivudine (3TC) / Efavirenz (EFV)

Primary Outcome(s)

Proportion of patients with plasma HIV RNA < 50 copies/ml

Secondary Outcome(s)

Variation of circulating CD4+ lymphocyte count

Variation of circulating total lymphocyte count

Proportion of patients with plasma HIV RNA <50 copies/ml

Pharmacokinetic parameters

Collection, analysis and if applicable reporting of Adverse Events

Incidence of resistance mutations after confirmed treatment failure (confirmed HIV RNA >1000 copies/ml)

Mean HIV log10 reduction compared to baseline

Proportion of clinical events stage 3 or 4 of WHO HIV classification

Proportion of patients with plasma HIV RNA < 400 copies/ml

Source(s) of Monetary Support

EDCTP

French National Agency of Research On Aids and Viral Hepatitis (ANRS)

European and Developing Countries Clinical Trials Partnership (EDCTP)

German Federal Ministry of Education and Research

Secondary Sponsor(s)

French National Agency of Research On Aids and Viral Hepatitis (ANRS)

Ethics review

Status: Approved
Approval date:
Contact:

Institutional Ethics review board of Munich University

Status: Approved
Approval date: 30/03/2012
Contact:

Comite National D'Ethique Et De La Recherche (CNER)

Status: Approved
Approval date: 23/07/2012
Contact:

National Institute for Medical Research