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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

NCT01714414 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-03-07

No results posted yet for this study

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.

Conditions

  • HIV-1 Infection

Interventions

DRUG

FZD

DRUG

3TC

DRUG

EFV

DRUG

AZT

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Treichville Academic hospital center, Division of infectious and tropical diseases (SMIT)

    collaborator UNKNOWN

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Kumasi Centre for Collaborative Research (KCCR)

    collaborator OTHER

  • Bernhard Nocht Institute for Tropical Medicine

    collaborator OTHER_GOV

  • Pharmaceutical Company (Chiracon GmbH)

    collaborator UNKNOWN

  • Pharmaceutical Company (STADA Vietnam Joint Venture Co. Ltd.)

    collaborator UNKNOWN

  • Michael Hoelscher

    lead OTHER

Principal Investigators

  • Michael Hoelscher, Prof. · Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich, Leopoldstrasse 5, 80802, Munich, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-06-30
Completion
2017-02-28

Countries

  • Côte d’Ivoire
  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01714414 on ClinicalTrials.gov