“A multicentre phase III trial of second-line antiretroviral treatment strategies in African adults (Tanzania and South Africa): The ALISA Trial”
Issakwisa Mwakyula (Principal Investigator), Tessa Lennemann, Arne Kroidl (Clinical Research Coordinator)
The ALISA Trial is a second line antiretroviral treatment study
The ALISA trial is a phase III , multicentre, non-inferiority, randomized, non-blinded second line antiretroviral treatment study evaluating the virological response (plasma HIV RNA<50 copies/ml) at 48 weeks of two antiretroviral treatment regimens in HIV-1-infected patients with treatment failure after first line antiretroviral therapy.
The primary objective is to demonstrate the non-inferiority of a generic Lamivudine-Tenofovir-Atazanavir/Ritonavir regimen as compared to a standard Emtricitabine-Eenofovir-Lopinavir/Ritonavir regimen after failing first line antiretroviral treatment including a non nucleoside reverse transcriptase inhibitor at 48 weeks.
Overall 386 HIV infected patients on failing first line antiretroviral therapy defined as confirmed virological failure >1000 copies/ml will be 1:1 randomized into one of the treatment arms.
The Mbeya Referral Hospital (MRH) supported by MMRC will participate in the trial enrolling 193 participants. The trial is expected to provide capacity building for the MRH clinics and laboratories as well as for the Tanzanian Southern Highlands HIV Programme in terms of HIV viral load monitoring and genotypic resistance testing. The trial is expected to start in August 2011.
The ALISA Study is funded by the European and Developing Countries Clinical Trials Partnership Programme (EDCTP) sponsored by the French Agence Nationale de Recherches sur le Sida et les hépatites virales (ANRS)
- NIMR-Mbeya Medical Research Center (MMRC) in collaboration with the Mbeya Referral Hospital (MRH) Mbeya, Tanzania
- University of Limpopo Medunsa Campus in Pretoria, South Africa.
- University of Montpellier, France
- University of Munich, Munich, Germany
- Institute of Tropical Medicine in Antwerp/Belgium
- University of Geneva/MSF
The LMU Department of Infectious Diseases and Tropical Medicine participate in this trial providing study coordination and management of the laboratory services. Logistical support is provided through the Munich office within the NIMR-MMRC collaboration.