Status:
COMPLETED
PI or NNRTI as First-line Treatment of HIV in West Africa - the PIONA Trial
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital Skejby
Bandim Health Project
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
BACKGROUND: Since 1996 the combination of three or more drugs has been the mainstay of human immunodeficiency virus (HIV) treatment. The most important types of drugs are called nucleotide reverse tra...
Eligibility Criteria
Inclusion
- Antiretroviral treatment (ART) naïve HIV-1 infected patients. Women receiving ART during pregnancy can be included.
- Age ≥ 18 years
- CD4+ cell count ≤ 350 cells/µL and/or
- Clinical signs of immune suppression (WHO clinical stage 3 or 4) irrespective of CD4+ cell count.
Exclusion
- Tuberculosis (TB) treatment with rifampicin at the time of enrolment.
- Co-infection with HIV-2.
- Grade 3 or 4 alanine transaminase (ALAT) elevation (\>5 times upper normal limit).
- Patients with cerebral disturbances that complicates the ability to give informed consent or follow the treatment regime.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01192035
Start Date
May 1 2011
End Date
September 1 2014
Last Update
June 25 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro de Tratamento Ambulatoria do Hospital Nacional Simão Mendes
Bissau, Guinea-Bissau