HIV/AIDS
Conditions
Interventions
Fozivudine (FZD) / Lamivudine (3TC) / Efavirenz (EFV)
Zidovudine (AZT) / Lamivudine (3TC) / Efavirenz (EFV)
Sponsors
Klinikum der Universität München, Prof. Dr. med. Burkhard Göke
French National Agency of Research On Aids and Viral Hepatitis (ANRS)
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with plasma HIV RNA < 50 copies/ml | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with plasma HIV RNA 1000 copies/ml);Variation of circulating total lymphocyte count;Variation of circulating CD4+ lymphocyte count;Pharmacokinetic parameters;Proportion of clinical events stage 3 or 4 of WHO HIV classification;Collection, analysis and if applicable reporting of Adverse Events | — |
Countries
Cote Divoire, Tanzania
Contacts
Public ContactOtto;Ulrich Geisenberger;Braun
Project Management;Project Management
Outcome results
None listed