Clinical Trials: The History of & What’s New


The Yale AIDS Clinical Trials Program began in 1992 with the receipt of a large grant from the NIH to establish an AIDS Clinical Trials Unit (ACTU) as part of the ACTG trials network. Yale was subsequently awarded an NIH Clinical Program for Community Research in AIDS (CPCRA) grant which enabled the establishment of New England ProACT (Programs for AIDS Clinical Trials), a regional clinical research collaborative consisting of sites in Connecticut and Massachusetts.

The Program has also received an NIH RO1 grant specifically directed at performing pharmacokinetic and pharmacodynamic drug interaction studies. In addition to these federally funded programs, the Yale Clinical Trials Program has been awarded dozens of single site investigator initiated studies and multiple-site grants from industry sources. Since 1992, the clinical trials program has enrolled 1,658 patients in 107 separate phase I-IV trials.

Program Staff

Dr Gerald Friedland served as the Director of the AIDS Clinical Trials Program and PI on NIH grants from its inception to 2008.  Dr Michael Kozal assumed the role of Associate Director, 2005-2009 and became Director of the Yale HIV Clinical Trials Program from 2009-2017.  Both Dr Friedland (past) and Dr Kozal (currently) have been members of DHHS/NIH Panel on Antiretroviral Guidelines for Adults and Adolescents, the national body that provides guidelines on the use of antiretroviral therapy.

This year, Dr Onyema Ogbuagu has been appointed as the third and now current Director of the AIDS Clinical Trials Program. Other AIDS Program faculty involved in the program over time have included include Drs Liz Cooney, Doug Bruce, Rick Altice, Brinda Emu as well as a substantial number of ID fellows.

The program has had the benefit of the longstanding contributions of both expert and essential staff including:

Laurie Andrews RN MPH | Program Manager

Cyndi Frank RN PhD | Clinical Research Nurse (not pictured above)

Jackie Baron | Regulatory Coordinator

Suzie Mutic | Research Assistant

Clinical Trials

Research in The Yale AIDS Clinical Trials Program is patient oriented and has focused on under served and vulnerable populations locally, nationally and at the international level.  The ACTG trials involved study of multiple new antiretroviral drugs and regimens. The studies conducted through the CPCRA network have primarily been large clinical outcome randomized control strategy trials, designed to determine the most appropriate and beneficial use of currently available antiretroviral therapy. These have included the FIRST study, comparing 3 different approaches to initial treatment for HIV, the MDR study, comparing ongoing treatment to a strategic treatment interruption in patients with multiple drug resistant HIV,  the SMART study, addressing the issue of antiretroviral stopping “or drug holidays” and the most recent and impactful START study, an international collaborative effort to compare viral suppression, regardless of CD4 to a medication conservation strategy, based on CD4 count.

This trial has provided the needed RCT evidence that antiretroviral therapy is of significant benefit at all CD4 cell counts, resulting in the current national and global recommendation of providing ART to all people living with HIV, regardless of CD4 cell count.  The Yale AIDS Program has also made significant contributions to these NIH trials networks in a series of studies of antiretroviral resistance and ultra deep sequencing (Kozal) and medication adherence (Friedland and Andrews)

In addition, a particular strength of the program has been the performance of pharmacokinetic and pharmacodynamic studies of drug interactions between antiretroviral therapies and drugs used to treat substance use (methadone and buprenorphine) and TB and HCV infection (Friedland, Bruce and Altice). In doing this work, in addition to developing and implementing treatment protocols, we have been one of the few academic clinical research centers in the country able to conduct and successfully complete such studies in people who inject drugs.

This work has been supported by an RO1 grant from National Institute on Drug Abuse (NIDA) and multiple industry sources. Further, Dr Kozal has been responsible for attracting large numbers of interesting and exciting studies of new classes of antiretrovirals from industry sources including, Yale investigator initiated studies, participation in multi-site trials and most recently the only regional site to study Maturation Inhibitors, Attachment Inhibitors and perform monoclonal antibody trials.

The Clinical Trials Program, under Dr Ogbuagu’ s direction continues to encourage and support industry, research foundations and government trials and Yale-based independent investigators conducting basic science and clinical research within the Yale HIV clinics and Yale-New Haven Health system.

Trials Active Enrolling

  • CytoDyn PRO 140 Monotherapy for the chronic suppression of CCR5-tropic HIV infection (PI-Ogbuagu)
  • Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE (A5332): NIAID/NHLBI (PI-Kozal)
  • A Multi-center, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 (humanized monoclonal antibody to CCR5) in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects. (PI-Ogbuagu)
  • Protocol TMB-311 study – A Phase 3, Multicenter Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected with Multi-Drug Resistant (MDR) HIV-1. (PI- Emu)

Ongoing Trials – closed to enrollment

  • Comparison of Truvada vs Descovy for PrEP in HIV negative gay men or transgendered women. GS-US-412-2055 (PI-Ogbuagu)
  • Strategic Timing of AntiRetroviral Treatment (START) INSIGHT PROTOCOL: NIAID (PI- Friedland)
  • BMS AI438-047: A Multi-Arm Phase 3 Trial of BMS-663068 (Attachment Inhibitor) in Heavily Experienced HIV-1 Subjects with MDR HIV (PI- Kozal)
  • MERK-Edge: A Phase III Clinical Trial of MK-5172 + MK-8742 in Subjects with Chronic HCV GT1, GT4 and GT6 infection who are on Opiate Substitution Therapy. HIV+ or Negative (PI-Altice)

Ongoing Trials that will be completed in 2017

  • GS-US-366-1216: A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) (PI- Kozal)
  • GS-US-366-1160: A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching from a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects. (PI- Kozal)

For information about Clinical Trials and Enrollment:

Laurie Andrews, RN, MPH | Phone: 203-785-3557

Cyndi Frank RN, PhD | Phone: 203 785-6939



From the Program Director:

On November 11, 2016, we held a half-day Faculty Retreat in the TAC Building. We started out with lunch and a birthday celebration for Dr. Friedland! We had a great turnout considering some of our faculty and staff members were unable to attend due to scheduling conflicts however we hope to have more retreats in the future.

To view photos from the retreat, click here.

Our goals for the retreat were to give brief updates on our current major activities in the areas of research, education, clinical work and community collaborations. In doing so, we hoped to promote programmatic collaboration with each other as well as new trainees and improve our local, national and international impact. A tangible outcome would be to produce an updated version of our Annual Report which would be available on line.


  • CLINICAL WORK – Focus on improving HIV testing in the ED; implementing PrEP; treatment of HIV/HCV patients
  • EDUCATION – Need for formal faculty development; need for enhancing our use of technology for teaching
  • MENTORSHIP AND RECRUITMENT – Need for creating events for trainees to expose them to activities in AIDS Program; need to better use website to link Fellows and trainees to potential mentors in AIDS Program
  • BASIC RESEARCH – Focus on Immunology, Neuropathogenesis, Oncology
  • CLINICAL TRIALS– Increased role of injectables for long acting ART, monoclonal Abs and vaccines and impact on clinical practice
  • IMPLEMENTATION RESEARCH– Focus on decision science including role of networks, providers, personal narratives in influencing prevention and care approaches; promoting integrated care networks in various national and international arenas (HIV/TB; management of substance use disorders, women’s health issues, renal transplantation, promotion of retention in care); promoting collaborative learning environments with multi-disciplinary stakeholders


This is our first edition of the AIDS Program Online Newsletter with Mitzi Perez as our content creator and organizer. Our goals are:

  1. Keep everyone associated with the AIDS Program informed of program activities
  2. Reach out to others in the broader academic community who might be interested in working with the AIDS Program.

This is a work in progress and is in response to suggestions made at our faculty retreat (see below):

  • Maintain a departmental online newsletter with links to relevant resources
  • Provide online updates of faculty profiles and program activities
  • Create brief video profiles of each faculty member as recruitment tool. We will be contacting you to schedule a convenient time for a video interview.

YALE AIDS Program Faculty Retreat Attendees

Row 1: Frederick Altice / Nancy Angoff / Lydia Barakat / Raffaele Bernardo
Row 2: Dana Dunne / Jennifer Edelman / Brinda Emu / Margaret Fikrig
Row 3: Gerald Friedland Ritche Hao / Michael Kozal / Priti Kumar
Row 4: Maricar Malinis / Jaimie Meyer / Onyema Ogbuagu
Row 5: Julia Rozanova / Sheela Shenoi / James Shepherd / Sandra Springer
Row 6: Serena Spudich / Richard Sutton / Merceditas Villanueva / Michael Virata
Row 7: Jeff Wickersham / Julie Womack / Heidi Zapata / Alexei Zelenev

The key contact person for our online newsletter is Mitzi Perez.



We hope to update this site in real time therefore please forward any newsworthy items to Mitzi. We will feature different aspects of the AIDS Program on a quarterly basis.

I look forward to what this newsletter can bring to our department in regards to maintaining an ongoing connection with everyone.

Ditas Villanueva