CAMPO Clinical Trials Program

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ABSTRACT OF THE CLINICAL TRIALS PROGRAM The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1 will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000 HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIV- positive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions. Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify immune response correlates of HSIL regression. The CAMPO Clinical Trials Program has the following aims: (1) To identify optimal screening strategies among HIV-positive women in Mexico and Puerto Rico for cervical HSIL detection, including cytology, HPV extended-typing, oncoprotein E6/E7 testing and methylation markers; (2) To determine the safety and efficacy of Visbiome™ probiotic on cervical and anal HSIL regression and reduced persistence of high-risk HPV infection in HIV-positive women and men in Mexico and Puerto Rico; and (3) To determine the safety and efficacy of a novel therapeutic vaccine on cervical and anal HSIL regression in HIV-positive women and men in Mexico and Puerto Rico. The Clinical Trials Program will be led by Dr. Joel Palefsky (Contact MPI) and co-led by Dr. Jorge Salmerón (MPI) of the INSP. The Protocol Chairs of the three studies are Dr. Jorge Salmerón (Study 1), Dr. Josefina Romaguera of UPR (Study 2), and Dr. George Sawaya of UCSF (Study 3). Protocol Teams for each study will be comprised of the Protocol Chair, representatives of each CAMPO Core, a representative from Emmes, and investigators from all three sites with relevant expertise and interest. Each of the studies is highly innovative. Study 1 uses new approaches for recruitment and performance of cervical screening in HIV-positive women and will include cost-effectiveness and quality of life analyses. Study 2 will test the safety of a probiotic for treatment of HSIL in HIV-positive women and men and its ability to reduce the risk of persistent hrHPV infection among those without disease. Study 3 will test a novel therapeutic vaccine for treatment of HSIL that covers multiple hrHPV types and HPV proteins. We expect the results of the three studies to change the paradigm of both screening and treatment of HSIL, with the potential to substantially reduce the incidence of cervical and anal cancers in HIV-positive women and men in Mexico and Puerto Rico. Our results will be broadly applicable to other populations in the Latin America and Caribbean region, and to a large extent, to Hispanic and other women in the U.S.