A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intesification with Maraviroc and Dolutegravir with No Intesification or Intesification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
- Question: This is a Phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC) and Dolutegravir (DTG) to the current antiretroviral therapy (ART) of HIV-infected individuals with undetectable (<50 copies/mL) plasma HIV-1 RNA, who have mild to moderate neurocognitive impairment, with a primary outcome of improvement in neurocognitive performance.
- POP: Subjects will have HIV-associated neurocognitive disorder (HAND) as defined by the Frascati criteria, plasma HIV-1 RNA <50 copies/mL within 90 days prior to entry, and no more than one plasma HIV-1 RNA ≥ and <200 copies/mL within 90 days prior to entry, and no more than one plasma HIV-1 RNA ≥50 and <200 copies/mL in the past 6 months prior to entry with a subsequent palsma HIV-1 RNA <50 copies/mL, and on stable ART for at least 12 months prior to entry with no plans to change treatment.
- Medication:At entry, subjects will be randomized to one of the following
- Arm A: Add to their existing ART: placebo for MVC and placebo for DTG
- Arm B: Add to their existing ART: DTG and placebo for MVC
- Arm C: Add to their existing ART: MVC and DTG
- Duration: 96 weeks
- Contact: Susan Blevins, 919-843-8763 or Jonathan Oakes, 919-966-6712
HVTN 703/HPTN 081: A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition on HIV-1 infection
- Question: To evaluate the safety and tolerability of VRC01 monoclonal antibody (mAb) administered through IV infusion; determine if the VRC01 mAb prevents HIV-1 infection; and to estimate the level of efficacy
- Population: HIV-uninfected 18 to 50 year old men and transgender individuals who have sex with men
- Medication: VRC01 human monoclonal antibody (mAb)
- Duration: Approximately 22 months with monthly visits
- Call: Chris Evans, ANP-BC, 919-843-8759 or Alex Delaney, 919-966-8353