MHRP was recently selected by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) and the AIDS Clinical Trials Group (ACTG) to participate as a Clinical Trials Unit (CTU).
ACTG was established by the NIAID in 1987 and supports the largest network of expert clinical and translational investigators and therapeutic clinical trials units in the world.
The MHRP CTU includes two Clinical Research Sites (CRS) in Kericho and Eldoret, Kenya.
Background
In early 2001, MHRP partner Dr. Frederick Sawe established one of the largest and successful “Prevention of Mother to Child Transmission (PMTCT)” programs in East Africa at the Kenya Medical Research Institute/Walter Reed Project HIV Program site in Kericho, Kenya.
Based upon the existing expertise and critical need to address a research question relevant to the larger Kericho area, the Kericho site was eager and poised to participate in an ACTG Phase III therapeutics study called “OCTANE” (Optimal Combination Therapy After Nevirapine Exposure). This was the first phase III therapeutic efficacy trial for MHRP outside the U.S.
The OCTANE study aims to address the critical question in Africa around nevirapine resistance in mothers who had received single dose nevirapine in the context of PMTCT of HIV/AIDS and need to subsequent receive triple therapy (including nevirapine). With support from Dr. Mary Marovich in Rockville and the University of San Diego, California, Dr. Sawe and Dr. Doug Shaffer opened the OCTANE study in May 2006, one month following the opening of MHRP’s first HIV vaccine study in Kericho. The Kericho team quickly established itself as a lead site among ten in Africa by immediately enrolling women in the study and for excellence in adherence to Good Clinical Practices (GCP).
Also in Kenya, the Moi University clinical research site (based upon a collaboration between Indiana University and Moi University) opened OCTANE. Lead by Dr. Abraham Siika, the Eldoret site also excelled in executing OCTANE.
The success in Kericho laid the foundation for MHRP (already a network partner with DAIDS for HIV vaccine research) to become a CTU within the ACTG. Dr. Doug Shaffer is the Principal Investigator for the MHRP CTU. Dr. Fred Sawe and Dr. Abraham Siika are the PIs for the Kericho and Eldoret CRSs, respectively. As ACTG CRSs, both the Kericho and Eldoret sites will be participating in upcoming ACTG studies.
Future Studies
Dr. Sawe has been selected to be the protocol chair for a roll-over OCTANE study that will evaluate monitoring strategies (CD4, viral load at 3 vs. 6 month intervals) for women ending the OCTANE study. Both Kericho and Eldoret will also be conducting an ACTG study evaluating the best timing for initiation of antiretroviral therapy for patients with active tuberculosis. Finally, investigators within the MHRP CTU, as well as Kericho and Eldoret CRSs, will have the opportunity to generate research proposals and concepts that may eventually become ACTG sponsored research.