Clinical Trials

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

GS 292-1825
E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
https://clinicaltrials.gov/ct2/show/NCT02600819?term=GS+292-1825&rank=1
Interventions: Open-label once-daily FDC of E/C/F/TAF

Eligibility:
 HIV-1 infected adults
 ESRD on chronic HD
 HIV-1 RNA < 50 copies/mL
 On a stable ARV regimen
 No documented history of HIV-1 resistance to EVG, FTC, 3TC or TFV
 CD4 ≥ 200
 Hepatitis C infection allowed
Contact: June 668-0166

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

HIV Heart Failure Network
HIV+ patients with and without diastolic dysfunction to determine characteristics unique to this patient population.
https://clinicaltrials.gov/ct2/show/NCT02860156?term=duke+and+hiv&recr=O...
Inventions: No treatment provided

Eligibility:

• Age >40 years
• HIV antibody positive
• On HARRT for >60 months
• History of viral suppression as defined by most recent HIV RNA level <200 copies/ml performed in the past 6 months
• LVEF >50%
Contact: Deb Murray 668-0178, pager 970-3913

 

Switch Study GS-US-380-4030
Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Truvada or Descovy to a Fixed Dose Combination of B/F/TAF in HIV 1 Infected Subjects who are Virologically Suppressed.
 
Eligibility:
  • Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF
  • HIV-1 RNA <50 copies/ml
  • eGRF> 30mL/min
  • chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enrol

Interventions: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

Contact: June 668-0166, Pager 970-0332

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

 

Abbvie M16-153

Glecaprevir/Pibrentasvir in Treatment Naive Adults with Chronic Hepatitis C Genotype 1, 2, 4, 5 or 6 infection and Compensated Ciirhosis
Interventions: Glecaprevir / Pibrentasvir

Eligibility:

  • Treatment Naive adults Hepatitis C virus (HCV) Genotype (GT) 1, 2, 4, 5 or 6 infection
  • Positive  plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL
  • documented as cirrhotic, with a child-pugh score of less than or equal to 6

Contact: June 668-0166, Pager 970-0332

 

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. 
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
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