New and ongoing clinical research studies
at the VCU HIV/AIDS Center

General studies involving therapy of persons living with HIV

INSIGHT 001: START
Strategic timing of anti-retroviral therapy

The purpose of this randomized study is to determine in persons with a CD4+ cell count > 450/mm3 whether immediate initiation of highly-active antiretroviral therapy (HAART) is superior to deferral of HAART until the CD4+ cell count declines to 325 cells/mm3 or until symptoms develop. Sponsored by the National Institutes for Health (NIH). Status: Currently enrolling at the VCU Medical Center in Richmond, Va. Contact Vinnie Mitchell at (804) 828-6471. Daniel Nixon DO, Ph.D., is the Principal Investigator for the site.

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AIDS Clinical Trial Group (ACTG) studies

ACTG (A5001)
AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol. Version 4.0, dated 11/23/2009

ACTG (A5128)
Plan for Obtaining Informed Consent to use Stored Human Biological Materials (HBM) for Currently Unspecified Analysis. Version 3.0, dated 8/9/2007

ACTG (A5257)
A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naive HIV-1-Infected Volunteers. Version 2.0, dated 12/16/2009

ACTG (A5275) – A Pilot Study Evaluating the Effect of Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis, and T-lymphocyte Activation in HIV-1 Infected Individuals with Suppressed HIV-1 RNA and LDL Cholesterol <130mg.dL
The purpose of the study is to see how taking atorvastatin affects inflammation biomarker blood tests in people infected with HIV that do not need to take medicine for high cholesterol. In addition to observing the effects of atorvastatin on inflammation biomarker blood tests, this study will see if atorvastatin is safe for people with HIV who are also taking medication for HIV.

ACTG (A5294) – A Prospective, Phase III, Open-Label Study of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in HCV/HIV Coinfected Subjects (BIRTH)
The purpose is to see if adding a third drug to this combination is safe and whether it will help people with both HIV and HCV better fight their HCV. The third drug that this study is investigating has already been approved by the Food and Drug Administration (FDA) recently for the treatment of people who are infected with HCV alone.

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