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A5325 A Prospective Randomized Controlled Study to Evaluate the Effect of Isotretinoin on Immune Activation among HIV-1-Infected Subjects with Incomplete CD4+ T cell Recovery on Suppressive ART

  • Question: To evaluate the safety and tolerability of taking isotretinoin (a drug that is approved for use in the treatment of severe acne) at a high dose in HIV-infected subjects on antiretroviral therapy and whether it can help improve the immune system by repairing some of the damage that HIV does to a person’s immune system.
  • POP: HIV-1 infected adults who have been virologically suppressed on ART for at least 12 months and with CD4+T cell count <350 cells/mm3 at screening.   
  • Medication: Isotretinoin
  • Contact: David Ragan 919-966-2623

A5326 Safety, Pharmacokinetics and Immunotherapeutic Activity of an Anti-PD-L1 Antibody (BMS-936559) in HIV-1 Infected Participants on Suppressive cART: A Phase I, Double-Blind, Placebo-Controlled, Ascending Single Dose Study

  • Population:HIV infected men and women between the ages of 18-70 who are on ART and have had an undetectable VL for 2 years or more with a CD4 count ≥ 350.  
  • Medication: A single dose of BMS-936559, which is an anti-PD-L1 monoclonal antibody
  • Duration: 1 year
  • Contact: Becky Straub 919-843-9975 or email

The HXTC Study  A Phase I Study to Evaluate the Safety, Immunologic, and Virologic Responses of HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) as a Therapeutic Strategy in HIV-Infected Individuals Started on Antiretroviral Therapy During Acute And Chronic Infection 

  • Contact: JoAnn Kuruc 919-966-8533  

PHI 05 - QD Therapy with Dolutegravir/Epzicom for Acute HIV Infection

  • Question: Treatment of Acute HIV Infection with one tablet once a day
  • Population:   Acute HIV infection
  • Medication:Fixed-dose combination of dolutegravir and epzicom
  • Duration: 2 years (medication provided throughout)
  • Contact: Emily Barrows 919-966-7747

M14-004  A Randomized, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection (TURQUOISE-I)

M14-004 Optional Pharmacogenetic Sub-study
M14-004 Optional Pharmacogenomic Sub-study

  • Question: Safety and efficacy of investigational drugs in reducing the amount of HCV in blood
  • Population: Adult subjects diagnosed with chronic genotype 1 hepatitis C virus (HCV) infection and human immunodeficiency virus type 1 (HIV-1) and either have not taken medications to treat the HCV infection or  have been previously treated for HCV infection using pegylated interferon (pegIFN) and ribavirin (RBV) therapy and the therapy was not effective. Must have suppressed HIV RNA and currently taking one of the following ARV regimens:  Reyataz/Norvir/Truvada or Isentress/ Truvada.
  • Medication:  Investigational drugs ABT-450, ABT-267 and ABT-333
  • Duration: 60 to 72 weeks including 16-19 study visits to the study clinic
  • Contact:Susan Blevins, ANP - 919-843-8763 or pager (919) 216-9815