A HISTORY OF CRI
When CRI was established in the late 1980’s, AZT was the only antiretroviral drug available to people living with HIV/AIDS. Today there are over twenty-five drugs, and CRI’s clinical research has contributed to the approval of more than half of them. These medications offer new hope – and present new challenges. Despite longer life spans and better quality of living among people with HIV, many still struggle with side effects, metabolic changes, and viral resistance. That’s why CRI continually tests new treatments and strategies, yielding better options for combating drug resistance, more effective ways to reduce drug toxicities and side effects, and improved formulations of drugs that will hopefully increase medication regimen adherence.
In addition to our groundbreaking research, CRI is one of the only regional providers of expanded access HIV drugs. Expanded access programs give HIV-positive consumers access to drugs that, though fully reviewed for safety and efficacy, have not yet been formally approved by the FDA. In the months before a new medication appears on the market, expanded access provides a new treatment option to those who may otherwise have run out of options.
Finally, as part of CRI’s mission to provide access to the highest quality treatment for people with HIV, CRI serves over 7,000 clients in the Massachusetts HIV Drug Assistance Program (HDAP). HDAP ensures that health care and medications reach the people with HIV/AIDS most in need by providing financial assistance to help pay for HIV drugs and health insurance for eligible Massachusetts residents.
A timeline of CRI’s work in the HIV/AIDS epidemic…
- A group of activists, clinicians, and consumers hold a meeting at Boston’s Club Café that results in the creation of the Community Research Initiative (CRI) of New England.
- CRI and 15 other community-based agencies form the Community Based Clinical Trials Network (CBCTN) to study drugs for HIV/AIDS-related opportunistic infections.
- CRI creates a Scientific Advisory Committee with strong participation from consumers and ACT UP members to review CRI trials.
- CRI implements the HIV Drug Assistance Program (HDAP), a program of the Massachusetts Department of Public Health that provides financial assistance to help pay for HIV medications.
- CRI receives its first NIH grant Peptide T and its potential anti-HIV properties.
- CRI enrolls over 1,000 HIV clinical trial participants in the national Observational Database of people with HIV and AIDS from the New England region.
- CRI studies the effectiveness of acupuncture for pain management in people with peripheral neuropathy.
- CRI launches a Community Advisory Board (CAB).
- CRI studies thymopentin – the first potential immune-modulator medication.
- FDA approves stavudine (d4T) and lamivudine (3TC) – both studied at CRI.
- CRI is the world’s largest enroller for the first ever protease inhibitor clinical trial. The development of this protease inhibitor leads to the advent of HAART (Highly Active Antiretroviral Therapy). CRI prioritized women and had the largest number of female participants of any site in the world on this trial.
- CRI studies hydroxyurea in combination with didanosine (ddI) – continuing trials show that AZT in combination with ddI or ddC improves health. This is the beginning of combination therapy.
- HDAP program successfully and dramatically changes from covering clients who are on a single HIV drug to combination therapy at several times the cost without creating waiting lists or stopping services.
- CRI conducts the first study showing that dual protease inhibitors (ritonavir and saquinavir) are effective in treating HIV.
- CRI is selected to be one of the five sites in the world to begin clinical trials for T-20 (Fuzeon or enfuvirtide), one of a new and powerful class of drugs called fusion inhibitors.
- CRI launches a program and evaluation of the Massachusetts HIV Adherence Initiative with the MA Dept. of Public Health at 17 sites to help patients deal with complex dosing regimens associated with emerging therapies.
- CRI opens a satellite office in Springfield, Massachusetts, a community with one of the nation’s highest HIV prevalence rates.CRI takes on its first Phase I trial.
- CRI’s first HIV medication pill chart is distributed nationally and at international conferences.
- CRI holds its first Phase I trial for Fuzeon.
- CRI is funded by NIH in a collaboration with Yale University to participate in the Community Programs for Clinical Research on AIDS (CPCRA), now called INSITE.
- Dr. Cal Cohen presents findings on a new method for phenotypic resistance testing, an improvement over previous efforts to identify viral mutations, at the 7th Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.
- CRI implements the Comprehensive Health Insurance Initiative (CHII) to provide health insurance
- CRI research contributes to the FDA approval of tenofovir, the first nucleotide analog medication.
- CRI begins enrolling patients in the Strategies for Management of Anti-Retroviral Therapy (SMART) trial, which will go on to be the largest HIV/AIDS study in the world and provide critical data about the disadvantages of long-cycle treatment interruptions based on CD4 count.
- CRI starts its investigator-initiated pilot study, FOTO (Five Days On, Two Days Off), which indicates that some patients can take their medications only five days a week without reducing the drugs' effectiveness.
- CRI completes its first Proof of Concept trial and begins studying the novel protease inhibitor (PI) TMC114. When TMC114 (Prezista or darunavir) is later approved in 2006, it will be the first PI that remains effective even in patients previously resistant to all drugs in the PI class.
- Dr. Cal Cohen presents preliminary data on the FOTO study at the XV International AIDS Conference in Bangkok. The study goes on to receive international media attention, including from National Public Radio and The Boston Globe.
- CRI launches The 1500 Fund – a sustaining gift program for annual donors of $1500 or more – in honor of 15th year anniversary.
- CRI Boston and Springfield become part of expanded access study of tipranavir – a new protease inhibitor.
- CRI mourns the loss of Dr. Anne B. Morris, the Director of Research at our Springfield site. Dr. Morris is posthumously awarded the prestigious Red Ribbon Leadership Award at the United Nations on World AIDS Day, December 1.
- CRI begins conducting clinical trials for a CCR5 inhibitor, which if approved, will represent an entirely new class of drugs called entry inhibitors.
- In the summer, CRI opens multiple independent, investigator-initiated trials, including a continuation of the FOTO study with an expanded cohort of patients at sites in Washington, D.C., Florida, and Boston.
- CRI and WGBH-TV co-host event to promote the FRONTLINE documentary series, “The Age of AIDS.”
- CRI opens three new expanded access programs for raltegravir (an integrase inhibitor), etravirine TMC125 (a non-nucleoside (NNRTI), and maraviroc (an entry inhibitor).
- CRI opens three expanded access programs between December 2006 and March 2007 for the medications Isentress, Intelence, and Selzentry.
- CRI establishes partnerships across the country to create a small network of independent clinical trial sites.
- CRI’s Director of Research Dr. Cal Cohen and Executive Director Julie Marston receive the 2006 Wainwright Bank Social Justice Award recognizing nonprofits who have achieved outstanding success in addressing issues of social justice.
- CRI is named one of 70 study sites to research the START (Strategic Timing of Antiretroviral Treatment) Trial.
- CRI’s Dr. Cal Cohen presents research findings for FOTO Study at the Ninth International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland.
- HDAP enrolls over 5,000 people; 1,467 are enrolled in CHII.
- CRI honors all who have helped the organization lead the way in AIDS research for 20 years.
- Dr. Dan Skiest and the Springfield staff move to Baystate Medical Center and begin conducting HIV research under hospital auspices but remain part of CRI's network of clinical research sites.
- The first new HIV/AIDS medication to be approved in three years (a new NNRTI called rilpivirine) is approved by the FDA; CRI's Dr. Cal Cohen is lead investigator for a clinical trial (THRIVE) that led to its approval.
- A new once-daily HIV medication, Complera, is FDA-approved for treatment and becomes the second complete single tablet HIV regimen. CRI’s role in the THRIVE trial laid the groundwork for Complera's approval.