HIV Clinical Research
Clinical Trial Capacity
The University of Pittsburgh Clinical Research Site has over two decades of experience in conducting HIV/AIDS clinical research protocols sponsored by the NIH/DAIDS, industry and other sponsors. The site is a DAIDS-funded Clinical Research Site (CRS) for the AIDS Clinical Trials Group (ACTG) and the Microbicide Trials Network (MTN). The clinical research team consists of experienced staff with expertise in clinical, data management, fiscal and regulatory aspects of clinical trials. The CRS collaborates with numerous investigators and groups within the University of Pittsburgh and utilizes resources of the CTSI when possible. The site has an active and engaged Community Advisory Board.
Particular areas of active investigation in HIV therapeutics are evaluation/measurement of HIV reservoirs, interventions to impact latently infected cells, therapeutic vaccination, and potential treatments to reduce chronic immune activation in HIV-infected individuals. HIV prevention research focuses on topical microbicides and pre-exposure prophylaxis, especially early phase trials of new or novel agents. The site has the capacity to collect blood and tissue (rectal, cervical, CSF) within IRB-approved protocols from HIV-infected and uninfected individuals. Recruitment into clinical trials is facilitated by the research recruiters who maintain two ongoing, IRB-approved, HIPPA-compliant research volunteer registries for HIV-infected and uninfected men and women who are interested in research studies.
The Pitt Clinical Research Site has developed extensive collaborations within the university community, and with support of institutional resources the site has developed specialized abilities to perform studies that have a high degree of complexity, and intense monitoring and evaluation requirements. Specifically, the site has the following capacities:
- Specimen procurement/storage: CSF samples, genital tract secretions, gut and lymph node biopsies, leukapheresis to assess HIV reservoirs and inflammation/fibrosis
- Specialized markers of end-organ diseases: flow-mediated dilation (FMD), carotid intima-medial thickness (C-IMT), and DEXA scans
- Intensive PK sampling for drug-drug interaction studies
- Sampling and ex vivo HIV challenge of cervical, vaginal, and rectal tissues to assess pharmacodynamic effects of PrEP and microbicides
- Specialized sampling of pregnant women and their infants: blood, cervicovaginal secretions, cord blood, breast milk to assess exposure and potential toxicity of microbicides
Therapeutic Research (HIV+ participants)
Particular areas of active investigation in HIV therapeutics are evaluation/measurement of HIV reservoirs, interventions to impact latently infected cells, therapeutic vaccination, and potential treatments to reduce chronic immune activation in HIV-infected individuals. The Pitt CRS has a full range of clinical and laboratory resources required to support early phase trials of novel agents and immune-based therapies. Specifically, the CRS has established capacity to enroll participants into interventional trials involving administration of early phase compounds and intense evaluation of HIV reservoirs, including large volume phlebotomy, leukapheresis, rectal mucosa biopsy, CSF sampling, and collection of genital secretions. Additional resources include a certified Good Manufacturing Practice cellular products facility with experience in isolation of autologous HIV and production of autologous dendritic cell vaccines.
Prevention (HIV- negative participants)
The University of Pittsburgh CRS has extensive experience with early phase trials of candidate drugs for oral or injectable Pre-exposure Prophylaxis (PrEP) and topical microbicides (rectal and vaginal). The Pitt CRS is a leading domestic site for the Microbicides Trials Network (Co-PIs: Sharon Hillier, PhD and Ian McGowan, MD, PhD) with past and current participation in numerous early phase studies of rectal and vaginal products for HIV prevention. The CRS works closely with investigators in the Department of Obstetrics, Gynecology & Reproductive Sciences to efficiently and expertly conduct MTN studies in healthy women, pregnant women and adolescents. Additionally, in collaboration with Dr. McGowan, the site participates in non-Network trials of investigational rectal microbicides and other novel prevention interventions funded by NIH, industry and other grants. Under Dr. McGowan’s leadership and in conjunction with the MTN Network Lab, the CRS has developed the logistical and clinical expertise in the collection, processing and evaluation of rectal biopsies for PK/PD. In the area of oral PrEP, Dr. Ken Ho is collaborating with Dr. Ron Stall (University of Pittsburgh Graduate School of Public Health) on pilot studies of episodic (“vacation”) use of PrEP during periods of high-risk.
Division of Infectious Diseases
Academic Administrative Office
818 Scaife Hall
3550 Terrace Street
Pittsburgh, PA 15261
Center for Care of Infectious Diseases
Falk Medical Building
3601 Fifth Avenue
Pittsburgh, PA 15213
Patient Appointments: 412-647-7228