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The AIDS Clinical Trials Group (ACTG) has been at the forefront of HIV research since 1987, soon after the beginning of the epidemic. The ACTG is the largest HIV clinical trials organization in the world and has conducted major trials that have advanced the standard of care for people living with HIV in the United States and around the world. The ACTG includes many of the world's leading clinical researchers. The ACTG is funded by the National Institutes of Health (NIH) through the National Institute of Allergy and Infectious Diseases (NIAID).
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The Aids Clinical Trials Group (ACTG) was initially established in 1987 to broaden the scope of the AIDS research effort of the National Institute of Allergy and Infectious Diseases (NIAID). The ACTG established and supports the largest Network of expert clinical and translational investigators and therapeutic clinical trials units in the world, including sites in resource-limited countries. These investigators and units serve as the major resource for HIV/AIDS research, treatment, care, and training/education in their communities.
The work accomplished by the ACTG has had a profound impact on the well-being of persons infected with HIV-1. Clinical trials and laboratory studies conducted by the ACTG have made major contributions to optimizing antiretroviral therapy (ART), managing drug resistance, preventing and treating co-infections, evaluating acute and long-term toxicities, and demonstrating the importance of genetics in predicting drug toxicities. Results of these studies have helped establish the standards for the management of HIV disease and form the basis of current treatment guidelines. This progress in the treatment of HIV-1-infected individuals has resulted in dramatic reductions in death and illness due to AIDS in the U.S. and other countries of the developed world.
The mission of the ACTG is to develop and conduct scientifically rigorous research and therapeutic clinical trials in the U.S. and internationally that
Did you know?When HIV was discovered in the early 1980's no treatment was available. All current treatment options and guidelines are the result of thousands of people with HIV volunteering and participating in clinical trials. However, there is still a lot of work to do! By signing up to be part of a clinical trial, you can help improve HIV treatment for the future.
What is a clinical trial?A clinical trial is a well-planned research study carried out by doctors, nurses and other study staff members. Different studies will have different purposes, last different lengths of time, have different criteria for qualifying, and involve different tasks for participants. Some trials may involve taking an additional medicine while others could only involve simple blood or saliva samples. It's up to you to decide if any particular study is something you are interested in or not. If you are interested in participating in a study but concerned about what is involved, a study nurse or doctor will explain all the details, time requirements, and safety precautions to you before signing up. Even once you are enrolled in a study, you will be in close contact with the study nurses and doctors, study staff, and your physician- all of whom will gladly answer any questions and address any concerns you may have along the way. You are free to leave a study at any time and it will not affect the care you receive from your doctor.
What about safety?Federal, state and local government have strict rules researchers must follow to protect people taking part in clinical trials. These rules require each institution to have an independent Institutional Review Board (IRB). The IRB assures that the safety and rights of participants are protected and that studies are well planned. All research studies have to be approved by the IRB. Also, patients are monitored very closely throughout the study by the doctors and nurses to check for any side effects.
What about cost?Most studies will pay for all study related costs however you or your insurance will usually need to pay for any costs that are part of your routine care. In addition, you will be reimbursed for your travel expenses and you may get paid if a study requires a lot of your time or special tests.
If you are interested in participating in research, please contact us with any additional questions or concerns. Talk with your primary care provider about our current studies and any you are interested in to make sure they are right for you. To speak with a study nurse, call (617) 726-3819 for more information.
The Harvard/Boston Medical Center/Miriam Hospital AIDS Clinical Trials Unit (CTU) comprises a consortium of five Clinical Research Sites (CRS) located at Massachusetts General Hospital (MGH), Brigham and Women’s Hospital (BWH), Beth Israel-Deaconess Medical Center (BIDMC), Boston Medical Center (BMC) and the Miriam Hospital in Providence, Rhode Island. Each of the five CRSs is affiliated with the national AIDS Clinical Trials Group (ACTG) and throughout its 26-year history investigators of this CTU have made major contributions to therapeutic research in AIDS and have played a critical role in the scientific leadership of the ACTG.
As the principal investigator of the CTU, Dr. Daniel Kuritzkes oversees all scientific, clinical, laboratory and administrative aspects of the CTU and its component CRSs. Dr. Kuritzkes is a Professor of Medicine at Harvard Medical School and Chief of Infectious Diseases at BWH. Dr. Kuritzkes is also Chair of the national AIDS Clinical Trials Group.
A principal strength of the Harvard/BMC/Miriam Hospital CTU is the outstanding group of investigators and study staff located at each of the five CRSs- who are experienced, productive and well-respected leaders in HIV clinical research.
How can I learn more about Clinical Trials at other local Research Sites?
To learn more contact the CRS Study Coordinator at:
Beth Israel-Deaconess Medical Center: Andrea Kershaw, ANP: 617-632-7627
Boston Medical Center: Betsy Adams, RN 617-414-7082
Brigham and Women’s Hospital: Cheryl Keenan, RN: 617-732-5635
Miriam Hospital, Providence, RI : Pam Poethke, RN 401-793-4971
Brief Description: This is a phase I/II safety, dose-escalation, and preliminary efficacy study of romidepsin (RMD), a histone deacetylase inhibitor, in HIV-infected subjects with suppressed viremia on a PI-sparing regimen. Subjects will complete the study in 4 to 8 weeks. Participants will be admitted to the inpatient Clinical Research Unit and will be compensated for their time.
Purpose of this Study: The overall goal of this exploratory study is to identify single doses of RMD that are safe and well-tolerated in HIV-infected subjects with HIV-1 RNA levels < 50 copies/mL on a stable ART regimen and to assess the induction of HIV-1 expression in HIV-infected subjects with suppressed viremia by measuring plasma viremia using a single copy HIV-1 RNA assay prior to RMD dosing and at other defined time points after initiation of RMD dosing.
Requirements to Enter Study:
Brief Description: This study is an open-label, randomized, two arm pilot trial of isotretinoin therapy to compare the changes in expression levels of CD38/HLA-DR on CD8+ T cells after 16 weeks of treatment followed by 12 weeks of observation on ART alone. Arm A (Treatment) will receive isotretinoin at approximately 0.5mg/kg po once daily for 4 weeks, then increased to approximately 1.0 mg/kg po once daily for 12 weeks or Arm B (Control) No treatment. This is a 28-week study.
Purpose of this Study: The main purpose of the study is to evaluate the effect of isotretinoin on changes in expression levels of CD38/HLA-DR on CD8+ T cells, the safety and tolerability of isotretinoin in HIV-infected participants on antiretroviral therapy (ART).
Brief Description: This is a substudy of A5325. It will evaluate the change in CD4+ Tcell percentage in the lining of the intestines. Samples will be collected via colonoscopy with biopsies immediately prior to the start of A5325 study treatment and followed its completion at week 16. Nationally, targeted enrollment is 30 subjects.
Purpose of this Study: The main purpose of the study is to evaluate change in CD4+ T cell reconstitution in the lining of the intestines after treatment with isotretinoin.
Brief Description: This is a phase II, randomized double blind, placebo controlled trial to evaluate the safety and efficacy of Low Dose Methotrexate (LDMTX) on endothelial function, assessed by flow-mediated vasodilatation (FMD) of the brachial artery. Key inflammatory markers of CVD risk and T-Cell activation in the blood, and size of the HIV reservoir will be measured during the study. Subjects will be randomized to receive LDMTX or matching placebo. Subjects will take 5mg x 1 wk, 10mg x 11 wks and 15mg x 12 wks totally 24 weeks of drug/placebo followed by observation for an additional 12 weeks. This is a 24-week study.
Purpose of this Study: This study will assess the safety and effects of LDMTX on endothelial function (assessed by flow-mediated vasodilation of the brachial artery), key inflammatory markers of cardiovascular disease risk (high-sensitivity C-reactive protein), interleukin-6, soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir.
Brief Description: This is a randomized blinded study to see if pitavastatin can prevent heart disease and heart disease related deaths in people with HIV infection who are taking medications. Participant will be randomized to either Pitavastatin 4mg one pill daily or Placebo Pitavastatin on pill daily. Once enrolled, participants will take the drug/placebo for up to 6 years. Participants will be seen every 4 months. Subjects enrolled in the main study will have the option of enrolling into the substudy, which includes a cardiac CT scan. This is a study that will enroll 6500 people from several countries.
Purpose of this Study: The main purpose of this study is to determine the effects of pitavastatin as a primary prevention strategy for major adverse cardiovascular events (MACE) in HIV.
Brief Description: This trial is non-randomized, and an open label phase II study of Interferon-free therapy for Chronic Hepatitis C genotype 1 in persons with HIV-1 Co Infection receiving concurrent ART. The study drugs that will be provided are: ABT-450/r/ABT-267 (150/100/25 mg) po daily plus ABT-333 (250mg) po twice a day plus Ribavirin 1000-1200mg (based on weight) divided into 2 doses (twice a day). Subjects will be treated for either 12 or 14 weeks, but neither subjects nor providers will be able to choose duration of treatment. All subjects will be followed up to 48 weeks on study.
Purpose of this Study: The study is to evaluate the safety and tolerability of DAA+RBV therapy in subjects coinfected with HIV-1, to estimate the efficacy of DAA+RBV therapy in treatment-naïve HCV/HIV-1 coinfected subjects, as measured by the sustained virologic response at 12 weeks (SVR12) after DAA+RBV therapy discontinuation, where SVR12 is defined as HCV RNA in the blood less than the assay lower limit of quantification.
Brief Description: This study is for HIV/HCV coinfected individuals. Participants must have a new HCV infection (<24 weeks prior to initial A5327 screening). It is an open-label study using the new drugs Ledipasvir (LDV) and Sofosbuvir (SOF) in a fixed-dose combination (Ledipasvir 90/Sofosbuvir 400mg tablet). Participants will receive 8 weeks of the drug and be followed up for 24 weeks.
Purpose of this Study: The study is to evaluate HCV treatment response to SOF and daily LDV/SOF taken for 8 weeks as assessed by SVR12, defined as HCV RNA undetectable 12 weeks post-treatment in persons with existing HIV-1 infection who are acutely infected with HCV genotype 1 or 4.
Brief Description: This study is for HIV treatment-naive individuals. Participants must have no previous ARV treatment at any time prior to study entry. It is a phase II, single-arm, open-label, pilot study of dolutegravir (DTG) plus lamivudine (3TC). A total of 120 participants will be enrolled and followed for 52 weeks.
Purpose of this Study: The main purpose of this study is to estimate the virologic success rate after initiating DTG plus 3TC, to evaluate the safety and tolerability of DTG plus 3TC.
No studies are currently available
Dr. Raj Gandhi is the Clinical Site Leader for the Massachusetts General Hospital Clinical Research Site (CRS) and the Director of HIV Clinical Services and Education in the department of Infectious Diseases. He is also the director of the Harvard University Center for AIDS Research Clinical Core. Dr. Gandhi is an experienced HIV clinician and clinical investigator. He has had a leadership role in numerous protocols that have been implemented through the national AIDS Clinical Trials Group. Dr. Gandhi’s main research focus is in HIV reservoirs, the role of the immune system in controlling chronic viral infections, such as HIV, HBV and HCV and therapeutic vaccines.
Teri Flynn, MSN, ANP is the Harvard/Boston Medical Center/Miriam Hospital CTU Study Coordinator. Teri has had a leadership role in clinical HIV research at the MGH since 1983 and has been involved with the ACTG since its inception in 1986. She serves on numerous national ACTG committees and works closely with the Community Advisory Board. Teri oversees the day-to-day operations of the MGH CRS.
Amy Sbrolla, BSN, RN is the Senior Research Study Nurse at the MGH Clinical Research Site. Amy has extensive research experience and has worked in the ACTG for over twelve years. Her national ACTG involvement includes protocol team and committee memberships. Amy had a leadership role in the Boston-based training for Botswana-HSPH Partnership CTU and traveled to Gaborone to help with on-site training as well.
Gilbert Roy, BS is the Regulatory Coordinator and the Senior Data Manager for the MGH Clinical Research Site. Gilbert has over twenty years of experience in the area of regulatory compliance and data management. He serves as the chief resource data management person for the Harvard wide ACTU. Gilbert also assisted in the training of the Botswana-HSPH Partnership CTU research study staff.
Eileen Ing, BA is the research assistant for the MGH clinical research site. Eileen graduated from Brown University with a B.A. in Community Health. Eileen assists with study recruitment and administrative support for the MGH study staff.
The Community Advisory Board (CAB) is a group of diverse community volunteers that provides input to the AIDS Clinical Trials Unit (ACTU). From the community prospective, the CAB provides a forum to voice concerns and discuss aspects of clinical trials such as protocol development, participant recruitment/retention, study implementation and research findings. This partnership between the CAB and the CTU has lead to increased community awareness and understanding of HIV treatments and the importance of HIV/AIDS clinical trials and HIV research.
Educational Awareness Sessions
The Community Advisory Board conducts three educational awareness sessions each year. The sessions are offered to persons living with HIV and include a:
Meetings and Membership
The Community Advisory Board meets quarterly at each of the Boston Clinical Research Sites which include: Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham and Women’s Hospital; and Boston Medical Center. Meetings are open to the public and provide an opportunity for CAB members and volunteers to:
How can I learn more or get involved with the Community Advisory Board?
If your organization or group would like to host an educational awareness session or if you would like to learn more about the CAB or becoming a member please contact:
Teri Flynn, MSN, ANP, CTU Coordinator Massachusetts General Hospital 617-726-3819
Mass General Hospital Cox Building, Room 626 55 Fruit St Boston MA 02114
Phone: (617) 726-3819 Email: email@example.com
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