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Tracy Swan, Treatment Action Group
HIV and hepatitis C are prevalent among current and former injection drug users (IDUs). For years, activists have been protesting the exclusion of people who use drugs from clinical trials of novel agents for HIV and hepatitis C. Excluding high prevalence populations from all research of new treatments is unacceptable, unless there is a compelling safety reason to do so.
Recently, exclusion criteria have become slightly less restrictive in some cases, leaving the investigator holding the bag, as it were. He or she is empowered to decide whether a person’s drug and/or alcohol use, dependence or abuse will interfere with the ability to participate in a trial—or if it could endanger study volunteers.
In theory, this is progress, but in practice, the impact is limited. Concerns about adherence and drug-drug interactions need to be addressed. Regular attendance at clinic visits may be a good indicator for the ability to participate in a clinical trial, rather than whether or not a person is using drugs and/or alcohol. Drug and alcohol use, dependence and abuse are not the same, and should be assessed with validated, easy-to-use tools such as the AUDIT-C. It may be possible to identify drug-drug interactions by in vitro studies—and if not, a safe way to gather this information must be determined.
Some drug-and alcohol-related exclusion criteria have become gospel, although the information they are based on may be limited or outdated. These have rendered drug and alcohol users ineligible for approved treatments and interventions, as well as clinical trials. Here are two examples:
HIV and hepatitis C trials for people who use drugs
The following listing of studies that are currently recruiting-or soon to open is compiled from:
http://clinicaltrials.gov
Unless listed under “international”, these trials are in the United States.
Listing these trials is not an endorsement or comment on either the research or trial design.
International
Adolescent Drug and HIV Prevention in South Africa
http://clinicaltrials.gov/ct2/show/NCT00336180
Methadone Maintenance & HIV Risk in Ukraine
http://clinicaltrials.gov/ct2/show/NCT00351026
Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
http://clinicaltrials.gov/ct2/show/NCT00142948
Project HERMITAGE: HIV Prevention in Hospitalized Russian Drinkers
http://clinicaltrials.gov/ct2/show/NCT00483483
Addiction Treatment in Russia: Oral vs. Naltrexone Implant
http://clinicaltrials.gov/ct2/show/NCT00218426
Hepatitis C Among Opioid addicts in Opioid maintenance Treatment in Zurich, Switzerland (HepCOP)
http://clinicaltrials.gov/ct2/show/NCT00473993
Prevention/Drug Treatment (HIV status not specified unless noted)
Computer-Assisted HIV Prevention for Young Drug Users
http://clinicaltrials.gov/ct2/show/NCT00182585
Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management Users
http://clinicaltrials.gov/ct2/show/NCT00292110
Drug Treatment Combined With Drug and Risk Reduction Counseling in the Prevention of HIV Infection Among Injection Drug Users (HIV negative)
http://clinicaltrials.gov/ct2/show/NCT00270257
Prisoners
Prison Buprenorphine
http://clinicaltrials.gov/ct2/show/NCT00574067
Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
http://clinicaltrials.gov/ct2/show/NCT00142935
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release (males only)
http://clinicaltrials.gov/ct2/show/NCT00367302
Hepatitis C (HIV status not specified unless noted)
http://clinicaltrials.gov/ct2/show/NCT00598416
A Video-Based HCV Curriculum for Drug Users
http://clinicaltrials.gov/ct2/show/NCT00241917
Improving Hepatitis C Treatment in Injection Drug Users
http://clinicaltrials.gov/ct2/show/NCT00148031
Study of the Effects of Motivational Enhancement Therapy on Alcohol Use in Chronic Hepatitis C Patients
http://clinicaltrials.gov/ct2/show/NCT00596960
Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users (for HIV-negative people only)
http://clinicaltrials.gov/ct2/show/NCT00194480
HIV Positive Women
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
http://clinicaltrials.gov/ct2/show/NCT00127231
HIV Positive or At-Risk Men
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-Risk HIV Behaviors
http://clinicaltrials.gov/ct2/show/NCT00497081
Aripiprazole Treatment for Methamphetamine Dependence Among High-Risk MSM
http://clinicaltrials.gov/ct2/show/NCT00497055
Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
http://clinicaltrials.gov/ct2/show/NCT00318409
Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users
http://clinicaltrials.gov/ct2/show/NCT00432926
12 Week Group Therapy Intervention for HIV+ Methamphetamine Users and Deliver It Within an HIV/AIDS Primary Care Setting.
http://clinicaltrials.gov/ct2/show/NCT00249678
Behavioral Therapy Development for Methamphetamine Abuse
http://clinicaltrials.gov/ct2/show/NCT00252434
Addressing Young Men’s Substance Use and HIV Risk
http://clinicaltrials.gov/ct2/show/NCT00325702
HIV-Positive: Women and Men
Comparison of HIV Clinic-Based Treatment With Buprenorphine Versus Referred Care in Heroin-Dependent Participants
http://clinicaltrials.gov/ct2/show/NCT00130819
Buprenorphine and Integrated HIV Care Evaluation
http://clinicaltrials.gov/ct2/show/NCT00124358
Directly Administered HIV Therapy in Methadone Clinics
http://clinicaltrials.gov/ct2/show/NCT00279110
Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
http://clinicaltrials.gov/ct2/show/NCT00218634
The Effects of Nutritional Supplementation and Drug Abuse on HIV
http://clinicaltrials.gov/ct2/show/NCT00149656
Pharmacotherapy for HIV+ Stimulant Dependent Individuals
http://clinicaltrials.gov/ct2/show/NCT00599573
The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration
http://clinicaltrials.gov/ct2/show/NCT00227357
Buprenorphine HIV Care Integration Project
http://clinicaltrials.gov/ct2/show/NCT00348868
References
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2. Ohnishi K, Matsuo S, Matsutani K, et al. Interferon therapy for chronic hepatitis C in habitual drinkers: comparison with chronichepatitis C in infrequent drinkers. Am J Gastroenterol. 1996 Jul;91(7):1374-9.
3. Okazaki T, Yoshihara H, Suzuki K, et al. Efficacy of interferon therapy in patients with chronic hepatitis C. Comparison between non-drinkers and drinkers. Scand J Gastroenterol. 1994 Nov;29(11):1039-43.
4. Anand BS, Currie S, Dieperink E, et al; VA-HCV-001 Study Group. Alcohol use and treatment of hepatitis C virus: results of a national multicenter study. Gastroenterology. 2006 May;130(6):1607-16.
5. Schaefer M, Schmidt F, Folwaczny C, et al. Adherence and mental side effects during hepatitis C treatment with interferon alfa and ribavirin in psychiatric risk groups. Hepatology. 2003 Feb;37(2):443-51.
6. Lucey MR, Brown KA, Everson GT, et.al. Minimal Criteria for Placement of Adults on the Liver Transplant Waiting List: A Report of a National Conference Organized by the American Society of Transplant Physicians and the American Association for the Study of Liver Diseases. Liver Transpl Surg. 1997 Nov;3(6):628-37.
7. Nickels M, Jain A, Sharma R, et al. Polysubstance abuse in liver transplant patients and its impact on survival outcome. Exp Clin Transplant. 2007 Dec;5(2):680-5.
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