Our research focuses on clinical trials in HIV and co-morbidities, hepatitis C (HCV), Hepatitis B (HBV), and influenza. Among patients living with HIV, hepatitis B and C have become major causes of morbidity and mortality. My team and I have been involved in patient-oriented research involving the epidemiology, clinical outcomes, and treatment of hepatitis B and C in patients co-infected with HIV. Additionally, we are focused on implementation studies to improve HCV testing and treatment among both baby boomers and among at risk individuals.
Hepatitis C (HCV)
HCV is a curable disease with the new directly acting antivirals. In order to significantly reduce the burden of HCV and its complications including hepatocellular cancer, we need to significantly increase testing in populations such as baby boomers (those born between 1945-1965) and among at risk individuals such as injection drug users, multiple sexual partners, and among men who have sex with men. We are implementing strategies to improve HCV screening and treatment at Parkland and other health care systems in North Texas. We have been involved in trials to examine the impact of care coordination in HCV treatment among HIV patients.
Hepatitis B (HBV)
We are part of NIH-funded multi-site network which is examining the impact of HBV treatment on liver disease progression. We have also been involved in examining the natural history of HBV in HIV patients and types of genotypes found in HIV population.
We have conducted many clinical trials using new therapeutics for the treatment of HIV. We also conduct studies related to cardiovascular disease in HIV patients, lipodystrophy, and liver disease. We have also been involved in trials to examine the role of patient navigators in HIV linkage and viral suppression. Among those in the trial, we found a high percentage of deaths during follow-up and we are currently examining what the causes of death are in this population.
We are involved in clinical trials which examine novel therapeutics for the treatment of influenza in hospitalized patients.
HIV-Infected Research Studies
- Theratechnologies, Inc - Diabetic Retinopathy in HIV Subjects Treated with EGRIFTA (EMR 200147-500): A prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate whether EGRIFTA® (tesamorelin for injection), 2 mg once daily SC, increased the risk of development or progression of diabetic retinopathy when administered to HIV-infected subjects with abdominal lipohypertrophy and concomitant diabetes. Duration of this study is approx. 3 years.
- EGRIFTA Observational Study (EMR-200147-501): A phase 4, observational, multicenter, 10-year prospective cohort safety study comparing subjects with HIV-associated abdominal lipohypertrophy exposed to EGRIFTA® (tesamorelin for injection) to a similar group of subjects not exposed to EGRIFTA®. Duration of the study is 10 years of observation. Subject will be seen every 6 months.
- REPRIEVE (A5332) - Randomized Trial to Prevent Vascular Events in HIV: HIV positive patients who are > 40 & < 75 Years of Age with a CD4 >100, on Stable HAART Therapy and NOT on a statin. Given Pitavastatin versus Placebo. Duration of the study is 6 years. Subject will be seen approx. every 4 months.
- HIV Research Database: This study is being done to create a database for future medical research on HIV disease and related conditions.
General Population Studies
- INPATIENT – IRC005 FLU Study: Clements Hospital: INPATIENT - Male or Female > 18 years of age and Flu Positive with anticipated hospitalization for more than 24 hours. This randomized, double-blinded, multicenter Phase 3 trial will assess the efficacy and safety of high-titer versus low-titer anti-influenza immune plasma for the treatment of severe influenza A. Duration of this study is 28 days.
- INPATIENT - FLU-IVIG Study (INSIGHT 006):Anti-Influenza Hyperimmune Intravenous Immunoglobulin Study. Duration of this study is 28 days. The subject is randomized in a 1:1 allocation to either IVIG plus standard of care (SOC) therapy or to placebo for IVIG (a comparable volume of normal saline) plus SOC.