drugset / Trial / NCT01714414
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
Phase 2
Completed
120 enrolled
Michael Hoelscher
ANRS, Emerging Infectious Diseases · collabBernhard Nocht Institute for Tropical Medicine · collabEuropean and Developing Countries Clinical Trials Partnership (EDCTP) · collabGerman Federal Ministry of Education and Research · collabKumasi Centre for Collaborative Research (KCCR) · collabNational Institute for Medical Research, Tanzania · collabPharmaceutical Company (Chiracon GmbH) · collabPharmaceutical Company (STADA Vietnam Joint Venture Co. Ltd.) · collabTreichville Academic hospital center, Division of infectious and tropical diseases (SMIT) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-12
- Primary completion
- 2014-06
- Completion
- 2017-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AZT | Unknown | 300 mg | Oral |
| Subject | EFV | Unknown | 600 mg | Oral |
| Subject | FZD | Unknown | 600 mg | Oral |
| Subject | FZD | Unknown | 800 mg | Oral |
| Subject | FZD | Unknown | 1200 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 150 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |