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

Klinikum der Universität München, Prof. Dr. med. Burkhard Göke0 个研究点目标入组 120 人开始时间: 2012年5月24日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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.

发起方

Klinikum der Universität München, Prof. Dr. med. Burkhard Göke