Treatment Naïve

A5308 - A Prospective, Single-Arm, Open-Label Study to Evaluate the Effect of Fixed-Dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumerate on T-Cell Activation, Absolute CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir in Treatment-Naïve HIV-1 Controllers

  • Population: 57 subjects
  • Medication: Fixed dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumerate (Complera)
  • Duration: 108 weeks (No ARV's the first 12 weeks, then Fixed-Dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumerate for 48 weeks and then can continue Fixed-Dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumerate or choose "no treatement for an additional 48 weeks)
  • Contact: Donna Pittard 919-843-6512

Effect of HIV infection and antiretroviral therapy on cerebral autoregulation

  • Question: HIV infection and antiretroviral therapy effects on cerebral blood flow
  • Population: 50 HIV positive treatment naïve patients and 50 HIV negative age, race, gender matched controls
  • Medication: None
  • Duration: 12 months
  • Contact: Megan Telfer 919-843-3482 or Prema Menezes 843-8607

GS-US-236-0128 (WAVES) - A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumerate HIV-1 Infected, Antiretroviral Treatment-Naïve Women

    • Question: To determine if the combination pill Stribild™ (EVG/COBI/FTC/TDF) STR is safe and effective in reducing levels of HIV-1 in the blood of female subjects who are treatment naïve (those who have not received any antiretroviral medication)
    • POP: Women > 18 years of age with HIV who are treatment-naive
    • MED: Stribild™, atazanavir (ATZ), Truvada®
    • DUR: About 1 year including a screening period of up to 35-42 days and 48 weeks of treatment. Subjects will be required to visit the clinic at a minimum of 10 times
    • CALL: David Ragan 919-966-2623 or Donna Pittard 919-843-6512

Substudies: Includes optional pharmacokinetic (oral contraceptive, hair specimen, and/or cervicovaginal fluid collection), DEXA, and FMD)

ING117172 (ARIA) - A Phase IIIb, Randomized, Open-Label Study of the Safety and Efficacy of Dolutegravir Abacavir/Lamiduvine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naive Women

    • Question: To demonstrate the non-inferior antiviral activity of DTG/ABC/3TC FDC once daily compared to ATV+RTV+TDF/FTC each administered once daily over 48 weeks in HIV-1 infected ART-naive women
    • POP: Women > 18 years of age with HIV who are treatment-naïve
    • MED: DTG/ABC/3TC FDC once daily or ATV+RTV+TDF/FTC FDC once daily
    • DUR: 48 weeks including 6 clinic visits
    • CALL: Donna Pittard (919) 843-6512