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- 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.
HIV Clinical Trials
|Description||The purposes of the study are to find out if men (cis or transgender) and transgender women would accept, tolerate and potentially use three different ways to potentially deliver anti-HIV drugs into the rectum when used before receptive anal sex and to evaluate if each study product is safe when applied rectally and used before anal sex.|
|Description||This is a study looking to see if a vaccine that is made from a person’s own white blood cells is safe and if it will result in an increase in the body’s immune system reaction to HIV. The study will be done in people living with HIV who are doing well on HIV medications.|
|Description||HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) is a study that will evaluate the safety and effectiveness of a new vaccine in HIV-1 infected persons. This vaccine is not meant to prevent HIV infection but rather to improve how your immune system responds to HIV infection. This study is to evaluate the safety and effectiveness of this vaccine. It is called a therapeutic or treatment vaccine.|
|Description||Long-Acting Antiretroviral Therapy in Non-Adherent Persons Living with HIV is a study for people living with HIV who have poor viremic response or are lost to clinical follow up with ART non-adherence for at least 6 month. This study uses cash incentives to motivate participants to be adherent with oral meds. Participants will be randomized to receive long active injectable ART after they are adherent on oral meds.|
A Phase I, First-in-Human, Ascending Dose Study of SAR441236, a Tri-specific Broadly Neutralizing Antibody, in Participants with HIV.
A5377 is the first study in humans of SAR441236. The study will enroll two groups of people with HIV: Arm A) People who are currently on an anti-HIV regimen with an undetectable HIV viral load will receive either SAR441236 or placebo in one of four increasing dosing groups. Arm B) People with HIV who have never received anti-HIV medications will receive SAR441236 in one of four increasing dosing groups. The study will safety and tolerability and collect information about the amount of the antibody in the blood over time.
A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in HIV-1-Infected Adults.
This study is for people who are infected with HIV-1 and have an undetectable viral load. We will evaluate the safety and effectiveness of a combination of two medications. The first drug is called cabotegravir (CAB). This will be given orally at first and then as an injection. The 2nd drug is called VRC-HIVMAB080-00-AB (VRC01LS). This is a monoclonal antibody. A monoclonal antibody targets human proteins rather than attacking the virus directly. This drug will be given intravenous (directly into a vein) for about 15 to 30 minutes. We are studying these medications to see if they work well when taken together to keep your virus levels low. This study will also evaluate the safety of the drug combination.
Division of Infectious Diseases
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Pittsburgh, PA 15261
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