The following list shows the current clinical research trials being conducted in our division and the Duke researchers associated with the respective initiatives.
HIV Treatment-Naïve
PHI 105
Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
https://clinicaltrials.gov/ct2/show/NCT02384395?term=duke+and+hiv&recr=O...
Interventions: Triumeq
Eligibility:
Acute HIV infection
Negative or indeterminate HIV screening test within 30 days of enrollment
Contact: Kara 668-0242, Pager 970-0791 or Laura 668-0165, Pager 970-7531
HIV Treatment-Experienced
REPRIEVE A5332
Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults.
https://clinicaltrials.gov/ct2/show/NCT02344290?term=duke+and+hiv&recr=O...
Interventions: Pitavastatin vs placebo
Eligibility:
HIV infection
On ART continuously for at least 6 mos
CD4>100
Low to medium risk for cardiovascular events -not on statin, -no history of CAD, PVD, MI, or stroke
Contact: Emily 668-5142, Pager 970-3898
HIV Neurocognitive Study: Project BRAIN
A Systems Biology Approach to HIV-associated Neurocognitive Impairment
Interventions: No treatment provided
Eligibility:
adults 18-59 years
HIV ≥5 years
nadir or pre-treatment CD4 count <350
Stable ART and no ART class changes for ≥1 year
HIV RNA (viral load) ≤50 copies/ mL
No contraindication to MRI or lumbar puncture
cocaine only, marijuana only, cocaine + marijuana, and non-drug users
Contact: Emily 668-5142, Pager 970-3898
HIV Reservoirs
Observational study investigating how HIV creates reservoirs in the body and more specifically the kidney.
Interventions: No treatment provided
Eligibility:
≥ 18 years
HIV +
Viral load ≥ 1000 in the past month or Viral load < 50 for the past 3 months
Contact: Laura M 668-0165, Pager 970-7531
Patient Perspectives on Chronic Disease Care in HIV-infected Persons
Observational study to determine patient perspectives on how non-HIV related chronic disease care is delivered to HIV-infected persons. Interview patients on their experiences in receiving care and their opinions on how to make it better.
Interventions:No treatment provided
Eligibility:
≥ 40 years
HIV +
At least one documented non-HIV chronic disease
Active antiretroviral therapy for ≥ 1 year
Been in care with HIV provider for ≥ 2 years
Contact: Laura M 668-0165, Pager 970-7531
HIV Biorepository
Database repository that allows archived clinical specimens and data to be stored and used for future research
Inventions: No treatment provided
Eligibility:
≥ 18 years
Current or former patient in the Duke Infectious Diseases Clinic
Contact: Meredith 668-3199
Tango
A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1 infected adults who are viroloigcally suppressed (TANGO).
Interventions: DTG+3TC vs. TAF based regimen
Eligibility:
- > 18 years of age
- HIV infected
- on uninterrupted TAF based regimen for at least 6 months
- at least 2 HIV-RNA measurements <50 copies/ml in the past 12 months
- No documented resistance or intolerance to DTG or 3TC
Contact: Laura M at 668-0165, pager 970-7531
HEPATITIS
Gilead HIV/HCV SWITCH-Registry
A Multicenter Clinical Registry to Monitor Antiretroviral Management in HIV/HCV Co-Infected Patients Initiating Direct Acting Antiviral Therapies for Hepatitis C Infection
Interventions: N/A (Registry study)
Eligibility:
dual HIV and HCV infections at time of starting HCV therapy
on a stable ARV regimen consisting of at least two active antiretrovirals for 12 weeks prior to switch (case) or start of HCV treatment (control)
received/initiated or is initiating a ledipasvir/sofosbuvir HCV treatment regimen
Contact: Emily 668-5142, Pager 970-3898
FLU / Parainfluenza / RSV
FLU 003+
-Observational Flu Study for Adults who are hospitalized with complications of Influenza
-Can be enrolled in FLU004 (sub study)
https://clinicaltrials.gov/ct2/show/NCT01056185?term=duke+and+hiv&recr=O...
Interventions: No Treatment provided; Deep nasal and oropharyngeal swab and blood draw
Eligibility:
Hospitalized for severe and/or complicated influenza
Contact: June 668-0166, FLU pager 970-4FLU
FLU 006 -
Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
https://clinicaltrials.gov/ct2/show/NCT02287467?term=duke+and+hiv&recr=O...
Interventions: IVIG vs. placebo
Eligibility:
Confirmed flu - hospitalized
Onset of illness <7 days
Contact: Laura 668-0165, Pager 970-7531
CMV Shire
Maribavir in Transplant Recipients with Cytomegalovirus (CMV) infections that are Refractory or Resistant to Treatment.
https://www.clinicaltrials.gov/ct2/show/NCT02931539?cond=cytomegalovirus...
Intervention"SHP620-303/Maribavir
Eligiblity:
- Refractory or resistant to treament with Ganciclovir, valganciclovir, Foscamet or Cidofovir
- Transplant receipent
- Non-HIV +
- >12 years old
Contact: Diane 668-5571, Pager 970-1348
Tuberculosis
LTBI Biomarkers Methodist Study
Immune Response to TB During treatment of Latent Infection
Intervention: None
Eligiblity: POsitive IGRA, HIV -, Contact from high incidence country
Contact: Laura F 668-0176
C. difficile
C Diff Shedding Study
Exploratory Study of Impact of Oral Metronidazole, Vancomycin and Fidaxomicin on the Extent and Quantity of Host Carriage and Environmental Contamination with C. difficile
https://clinicaltrials.gov/ct2/show/NCT02057198?term=duke+and+difficile&...
Interventions: Randomized to oral fidaxomicin, metronidazole or vancomycin
Eligibility:
C diff PCR +ve, not received more than 2 doses of anti-C. difficile medication for therapy
Contact: Rachel 668-5006
Fungal
Candidemia (Synexis)
Open Label study of SCY-078 in patients with invasive and/or severe Fungal Infections Refractory to or Intolerant of Standard Antifungal Treatment
https://clinicaltrials.gov/ct2/show/NCT03059992
Interventions: SCY-078-301
Eligibility:
- >18 years of age with documented eligible invasive and/or severe fungal disease
- refractory to/intolerant of/or not feasible to receive available antifungal treatment
Contact:Diane 668-5571, Pager 970-1348
Invasive Fungal Infection Registry (Astellas)
A Non-Interventional Registry Study of Systemic Antifungal Therapy in Adults with Invasive Mucormycosis or Invasive Aspergillosis Casued by a Non-Fumigatus species.
Intervention: 9766-CL-0111
Eligibility:
- Data collection, Retrospective
Contact: Diane 668-5571, Pager 970-1348
OTHER
MDRO UTI Fecal Microbiome
Examination of the fecal microbiome and markers for recurrence in patients with multidrug-resistant organism urinary tract infections no treatment.
Interventions: Urine and stool samples
Eligibility:
18 years of age or greater;
paitents with Gram negative MDRO UTIs
Contact: Kathy Foy 919-668-3833