The Institute’s Global HIV Clinical Trials Unit (CTU) has long been recognized for its scientific rigor, research excellence, and a consistent ability to meet complex regulatory compliance. Its systematic approach, vital to producing reliable and trustworthy evidence for new drug trials, ensures the safety and well-being of human participants are consistently met.
The CTU manages four Clinical Research Sites (CRS) that include Chapel Hill, Greensboro, Malawi, and Vietnam–connecting sites and participants with studies that advance life-changing therapies. Finding and reaching the right participants can be one of the most difficult clinical trial recruitment challenges. Before a clinical trial begins, researchers must ensure participants have all information needed to give their informed consent. It’s also important that participants know how a trial intervention differs from the available treatments already on the market.
From Start to Finish
Once a trial begins, participants are kept informed of updates and upcoming appointments, and how to prepare for them. Participants are also regularly reminded about the benefits of taking part in clinical trials, and the important role they play in helping to make effective new treatments available to patients. Once the clinical trial is over, participants are thanked for their valuable time. The hope is they will take part in future studies or recommend them to others.
Celebrating Successes
The Chapel Hill CRS recently acknowledged study accomplishments with a celebration catered by The Purple Bowl.
1.HPTN 114 Enrolled First Participant
The HPTN 114 is a Phase 2 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and neutralization capacity of three broadly neutralizing monoclonal antibodies—VRC07-523LS, PGT121.414.LS, and PGDM1400LS—in healthy adult participants without HIV. The study aims to assess these antibodies as potential tools for HIV prevention through antibody-mediated strategies.
2. Original Enrollment Goal for HPTN 106 Surpassed
HPTN 106 is a Phase 2 crossover study evaluating the extended safety, acceptability, and pharmacokinetics/pharmacodynamics of on-demand PrEP formulations—specifically comparing rectal and oral tenofovir-based PrEP—in HIV-uninfected men who have sex with men (MSM). The study aims to inform future HIV prevention strategies by assessing how these formulations perform in real-world, episodic use scenarios.
3. DMID 21-0018 Study Enrollment was Completed
DMID 21-0018 is a double-blind randomized controlled trial to test whether vaccination with 4C-MenB, BEXSERO™ (approved for protection against invasive disease with group B Neisseria meningitidis, provides protection from urethral infection with Neisseria gonorrhoeae in the controlled human male gonococcal infection model.)
4. Deliver-02 Enrolls First Participant
Deliver-02 is a Phase 1, open label, randomized study to evaluate the safety and tolerability of MGD014 andMGD020 with a latency reversal agent versus temporary treatment interruption in persons with HIV-1 onantiretroviral therapy.
5. MK8527-011 and Purpose-365
The CRS opened two new HIV PrEP studies (MK8527-011 and Purpose-365), both studying novel HIV prevention medications that offer longer duration therapies for people that would benefit from PrEP.
Network Leaders Express Gratitude
The Institute’s Director Myron Cohen and CTU’s Co-Director Joe Eron, leaders of the HPTN and ACTG respectively, also expressed their appreciation for the dedication of clinical research staff around the world, including the Chapel Hill CRS, especially during a challenging year for funding.
AIDS Clinical Trials Group (ACTG)
Dr. Joe Eron, ACTG Chair, and Dr. Rajesh Gandhi, ACTG Vice Chair – Message
HIV Prevention Trials Network (HPTN)
Dr. Myron Cohen and Dr. Wafaa El-Sadr, HPTN Principal Investigators – Message