PI or NNRTI as First-line Treatment of HIV in West Africa - the PIONA Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
HIV-1
Interventions
DRUG

Efavirenz or Nevirapine

"2 NRTIs (lamivudine 150 mg bis in die - twice a day (BID) and either zidovudine 300 mg BID if hemoglobin is ≥ 8 g/L or stavudine 30 mg BID if hemoglobin is \< 8 g/L) and 1 NNRTI (efavirenz 600 mg omne in die - once daily (OD) or nevirapine 200 mg OD for the first 2 weeks and after that 200 mg BID). Efavirenz will be used in all male patients according to national HIV guidelines. Pregnant patients and female patients with a child bearing potential will be treated with nevirapine if CD4+ cell count is ≤ 350 cells/mm3 with close monitoring of liver enzymes during the first 12 weeks in patients with CD4+ cell count \>250 cells/mm3. Females beyond childbearing age will be treated with efavirenz."

DRUG

Ritonavir-boosted lopinavir

2 NRTIs (lamivudine 150 mg BID and either zidovudine 300 mg BID if hemoglobin is ≥ 8 g/L or stavudine 30 mg BID if hemoglobin is \< 8 g/L) and 1 PI (ritonavir-boosted lopinavir 400/100 mg BID).

Trial Locations (1)

Unknown

Centro de Tratamento Ambulatoria do Hospital Nacional Simão Mendes, Bissau

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aarhus University Hospital Skejby

OTHER

collaborator

Bandim Health Project

OTHER

collaborator

Ministry of Health, Guinea-Bissau

UNKNOWN

collaborator

Abbott

INDUSTRY

lead

University of Aarhus

OTHER