Study name : A Pilot Study of Lopinavir/Ritonavir in Participants Experiencing Virologic Relapse on NNRTI-Containing Regimens
Research network (Code) : A5230
Principle investigator : Professor Khuanchai Supparatpinyo, MD
Funding agency : The National Institute of Allergy and Infectious Diseases
Study sites :
University of Witwatersrand, Johannesburg, South Africa
Chiang Mai University, Research Institute for Health Science, Chiang Mai
YRG Center for AIDS Research and Education, Chennai, India
University of Malawi/Johns Hopkins Project, Blantyre, Malawi
UNC Project Lilongwe, Kamuzu Hospital, Lilongwe, Malawi
Kilimanjaro Christian Med Center (KCMC), Tanzania
Study start : February 2008
Study design
An open-label, single arm pilot trial to explore the safety and efficacy associated with lopinavir/ritonavir (LPV/r) NNRTI based HAART-experienced, protease. All participants will receive LPV/r for up to 104 weeks. Upon confirmation of virologic failure, participants will receive emtricitabine (FTC)/tenofovir DF (TDF).
Study objectives
To evaluate the safety and virologic efficacy of LPV/r monotherapy in participants who have experienced virologic relapse on an initial NNRTI-containing regimen.
Significance
Most of AIDS patients in Thailand are treated with NNRTI based regimen. The results of this study will give medical doctors more choice of ART treatment for failure NNRTI based.
Progression
There have been only 3 out of 18 people who have to be changed the ART regimen due to poor adherence
