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 919-843-8607
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
LAI 2000056/LATTE 2 - A Phase IIB Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 plus TMC278 for the Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral regimen of GSK1265744 plus Abacavir/Lamivudine in HIV-1 Infected patients.
- Question: to evaluate the efficacy and safety of 2 long –acting parenteral (LAP) formulations of ARVs when both are administered as once-monthly IM injections.
- POP: adult males and females age 18+; females must be non-pregnant, non-lactating, on effective contraception
- MED: GSK744 LAP (new integrase inhibitor, long-acting parenteral formulation) plus TMC278 LAP (rilpivirine, long-acting parenteral formulation), with comparator arm of oral GSK744 + oral ABC/3TC. Participants are randomized to receive either oral or parenteral/ IM study drugs.
- DUR: induction phase (16 or 24 weeks), followed by 96 weeks of either IM or oral study drugs, followed by extension phase/option to continue with or switch to LAP form of drug
- CALL: Susan Blevins, ANP (919) 843-8763 or pager (919) 216-9815