Duke infectious disease specialists offer patients access to new therapies through participation in carefully designed clinical trials.
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
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
Open Label study of SCY-078 in patients with invasive and/or severe Fungal Infections Refractory to or Intolerant of Standard Antifungal Treatment
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)
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