HIV-1 Clinical Trial
Official title:
PI or NNRTI as First-line Treatment of HIV in a West African Population With Low Adherence - the PIONA Trial
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 transcriptase inhibitors (NRTIs), non-nucleotide reverse transcriptase
inhibitors (NNRTIs) and protease inhibitors (PIs) Response to treatment is measured as
increasing CD4+ cell count and decreasing HIV viral load. A major problem is the development
of resistance. NNRTIs are recommended as part of first-line treatment of HIV in Africa but
many Africans have a slower NNRTI clearance than Caucasians making them more susceptible for
development of resistance in case of treatment interruptions. PIs might therefore be a better
option in an African setting with low adherence.
AIM: To evaluate two different treatment regimens in HIV-1 infected patients:
A) A NNRTI (efavirenz/nevirapine) based regimen and B) A PI (ritonavir-boosted lopinavir)
based regimen with regard to treatment outcomes. HYPOTHESIS: Treatment with a PI will be
superior to treatment with a NNRTI due to less development of resistance.
METHODS: Treatment-naïve adult HIV-1 patients enrolled in an existing cohort The West African
Retrovirus and Acquired Immune Deficiency (WARAID) cohort in Guinea Bissau with CD4+ cell
count ≤ 350 cells/µL and/or clinical signs of immune suppression (World Health Organization
(WHO) clinical stage 3 or 4) will be randomised 1:1 to: Treatment A: 2 NRTIs (lamivudine and
either zidovudine or stavudine) and 1 NNRTI (efavirenz or nevirapine) or Treatment B: 2 NRTIs
(same as in treatment A) and 1 PI (ritonavir-boosted lopinavir). Primary outcome: Viral load
suppression <400 copies/ml 12 months after enrolment.
PERSPECTIVES: Guidelines for treatment of HIV in Africa are more or less a copy of the
guidelines used in Europe and North America. Genetic differences in pharmacokinetics, more
women infected in Africa and difficulties ensuring good adherence mean that results obtained
from Caucasian patients are not directly transferrable to African patients. The results of
this study will hopefully help guiding the treatment of HIV in Africa in the future. The
investigators believe the HIV infected people in West Africa deserve the same evidence-based
medicine as in developed countries.
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