HIV

Enrolling

Exploring the consequences of food insecurity and harnessing the power of peer navigation and mHealth to reduce food insecurity and cardiometabolic comorbidities among persons with HIV (HIV and Food Insecurity

This NIH-sponsored study seeks to better understand how food insecurity impacts the risk of cardiometabolic comorbidities in persons with HIV (PWH). All PWH followed in our clinic are invited to participate in a 3 year study looking at the impact of food insecurity and other social determinants of health on pre-diabetes and diabetes risk over time. Persons with pre-diabetes or diabetes and food insecurity are invited to participate in an intervention using peer support to improve access and utilization of community-based resources addressing food insecurity and metabolic disease. (Clinic lead investigators: Drs. Caryn Morse and Scott Rhodes)

Targeting Frailty in Aging Persons with HIV (Emerging Strategies to Improve Health Outcomes for People Aging with HIV: Demonstration Sites)

This HRSA-supported study integrates assessments for frailty in at-risk aging PWH and offers a 3-month tailored nutrition and exercise intervention to those with frailty and pre-frailty, assessing the intervention impact on frailty, mood, HIV and overall health. (Clinic lead investigator: Dr. Caryn Morse)

Electronic Frailty Index (eFI) in Aging Persons with HIV

In collaboration with the Wake Forest Claude Pepper Older Americans Independence Center, this study is evaluating an electronic-medical record based frailty index (eFI) for identifying persons with HIV at risk for complications of frailty, including falls, emergency department visits and hospitalizations. Persons with HIV age 50 and older are invited to participate in assessments to help validate the eFI, including comprehensive geriatric assessment, physical performance testing and blood biomarkers. (Clinic lead investigator: Dr. Caryn Morse)

HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evalution of a Locally Developed Intervention

Wake Forest University and its partners, Triad Health Project, and the University of North Carolina, Greensboro, are evaluating the effectiveness of ChiCAS (Chicas Creando Acceso a la Salud or Girls Creating Access to Health), a locally developed, Spanish language small group behavioral intervention that promotes access to and participation by Hispanic/Latina transgender women who are HIV negative and who have sex with men in pre-exposure prophylaxis (PrEP), medically supervised hormone therapy, and consistent condom use. Centers for Disease Control (CDC) funded study. (Lead investigator: Dr. Scott Rhodes)

Appalachian Partnership to Reduce Disparities

This study combines two strategies (peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially and ethnically diverse GBMSM and transgender women in rural Appalachia. Enrolling through community partner referral. (Lead investigator: Dr. Scott Rhodes)

North Carolina Rapid Antiretroviral Program for Individuals with a new HIV Diagnosis (NC-RAPID)

This study works with partners in the to provide immediate initiation of antiretroviral therapy for newly diagnosed persons with HIV. Piloted in Forsyth County, the study has expanded to Guilford and Mecklenberg counties. (Clinic lead investigator: Dr. Candice McNeil)

Study to Assess the Effectiveness and Safety of Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP)

Gilead Sciences is supporting this study of a long-acting injective antiretroviral for the prevention of HIV infection in persons at increased risk of HIV. Participants are randomized to either standard of care PrEP with Truvada or lenacapavir for 12 months with the option for open-label lenacapavir continuation up to 24 months. (Clinic lead investigator: Dr. Caryn Morse)

A Phase 2 Evaluation of VGX-3100, a Synthetic DNA Immunotherapy Targeting Human Papillomavirus 16 and 18 E6 and E7 Proteins, for Anal High-Grade Squamous Intraepithelial Lesions (HSIL) in HIV-Positive Individuals (AIDS Malignancy Consortium (AMC) 103)

This NIH-supported study is investigating the use of therapeutic DNA vaccine (VGX-3100) and electroporation for the treatment of PWH with high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body’s cells take in the drug to strengthen your immune system’s response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions. (Clinic lead investigator: Dr. Luis Barroso)

Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions

This NIH-supported randomized phase 3 trial studies imiquimod or fluorouracil to see how well they work compared to observation in treating PWH with high-grade anal squamous skin lesions. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether imiquimod or fluorouracil is more effective than observation in treating high-grade anal squamous skin lesions. (Clinic lead investigator: Dr. Luis Barroso)

Efficacy and Safety Study of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea

Glaxo Smith Kline-sponsored study compares oral gepotidacin to intramuscular ceftriaxone plus oral azithromycin for the treatment of gonorrhea in persons with HIV and persons without HIV. (Clinic lead investigator: Dr. Candice McNeil)

Clinical Evaluation of the Xpert Xpress CT/NG Test in Urine and Extragenital Specimens

This Cepheid sponsored study seeks to help develop point of care testing for the detection of sexually transmitted infections (STIs) in men and women. Participants will be asked to provide samples at a single time point only. (Clinic lead investigator: Dr. Candice McNeil)

No Longer Enrolling

Pathways to cardiovascular disease prevention and impact of specialty referral in under-represented racial/ethnic minorities with HIV (Pathways)

This NIH-sponsored study is being done in collaboration with Duke University, Medical University of South Carolina and Vanderbilt University. The overall goal of the study is to demonstrate the effect of cardiology referral on CVD health outcomes in a large racially/ethnically diverse cohort of people living with HIV (PLWH). The long-term goal is to generate evidence-based recommendations for the management of CVD risk in PLWH (Clinic investigator: Dr. Caryn Morse)

REPRIEVE: Randomized Trial to Prevent Vascular Events in HIV

NIH-supported trial evaluating if a statin medication (pitavastin) is effective in preventing heart disease among persons with HIV. REPRIEVE is the largest randomized trial to date in persons with HIV. Results from REPRIEVE will help in the development of heart disease prevention and treatment guidelines, specifically for people with HIV. Participants in the study are seen every 3-6 months at the time of their regular clinic visits. (Clinic lead investigator: Dr. Aimee Wilkin)

Anal Cancer/HSIL Outcomes Research (ANCHOR) study

The ANCHOR study enrolled persons with HIV age 35 and older with anal lesions at high risk for progression to anal cancer were randomized to two groups: treatment of concerning lesion(s) or active monitoring without treatment. The study recently published their findings that treating precursor anal cancer lesions can significantly reduce the risk of progression to full blown anal cancer among people living with HIV. Treatment and monitoring of participants is ongoing through 2025. (Clinic lead investigator: Dr. Luis Barroso)

Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection

This is a NIH-sponsored randomized, open-label, multicenter trial evaluating the efficacy of a single injected dose of penicillin G compared to three successive weekly injected doses for treatment of early syphilis in HIV-infected and HIV-uninfected persons. The study targeted enrollment of over 500 adults with untreated early syphilis (primary, secondary, or early latent) at 9 sites in the US. Participants are in follow-up through 2023. (Clinic lead investigator: Dr. Candice McNeil)

Coming Soon

Study to Evaluate drug GS-8588 in People With HIV-1 Who are Virologically Suppressed on Antiretroviral Therapy

Gilead Sciences sponsored study testing an experimental drug, GS-8588, for the treatment and remission of HIV infection. GS-8588 is an antibody that helps the immune system bring immune cells closer to the cells infected with HIV. Finding ways to target and destroy the hidden HIV in body cells is a major challenge facing HIV researchers who are exploring different strategies to find a potential cure for HIV. This study requires elective admission for study medication dosing and monitoring. (Clinic lead investigator: Dr. Caryn Morse)

A Phase 2 Randomized Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination with Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults with HIV-1 Infection

Gilead Sciences sponsored study evaluating two long-acting antibodies against HIV in combination with the long-acting injectable capsid inhibitor lenacapavir in persons with HIV that are doing well on antiretroviral therapy. The study medications offer the potential of every 6 month injectable/infusion HIV therapy as an alternative to daily or monthly therapies. (Clinic lead investigator: Dr. Caryn Morse)