A 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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Hoelscher
• Collaborators: ANRS, Emerging Infectious Diseases; Bernhard Nocht Institute for Tropical Medicine; European and Developing Countries Clinical Trials Partnership (EDCTP); French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS); German Federal Ministry of Education and Research; Kumasi Centre for Collaborative Research (KCCR); National Institute for Medical Research, Tanzania; Pharmaceutical Company (Chiracon GmbH); Pharmaceutical Company (STADA Vietnam Joint Venture Co. Ltd.); Treichville Academic hospital center, Division of infectious and tropical diseases (SMIT)
• Treatments: Efavirenz; Lamivudine; Zidovudine

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/μl

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.