Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users

NCT00270257 | Terminated Phase 3 Results DMC

• 2 other identifiers: HPTN 05810144
• Study Type: interventional
• Target: 1,251
• Locations: 2 countries
• Sites: 4

Brief Summary

Drug abuse and HIV/AIDS are serious global health problems. Injection drug use is currently the major mode of transmission of HIV in many countries. The purpose of this study is to determine the effectiveness of drug and risk reduction counseling combined with either substitution drug treatment with buprenorphine/naloxone (BUP/NX) or short-term detoxification with BUP/NX in preventing HIV transmission among injection drug users. Participants will be recruited for this study in China and Thailand.

Conditions

HIV Infections; Opioid-Related Disorders

Keywords

HIV Seronegativity; Opiate Addiction; Opiate Dependence

Outcome Measures

Primary Outcomes (1)

• Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks

  The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect.

  For visits up to week 104

Secondary Outcomes (6)

• Number of Participants With Urinalysis Results Positive for Opiates

  Measured through Week 104

• Self-report of Continued Injection Opiate Use in the Last 30 Days

  Measured through Week 104

• Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months

  Measured through Week 104

• Self-reported Number of Injections in the Last Month

  Measured through Week 104

• Incident Hepatitis C Infections for Thailand and China

  Measured through week 156 in Thailand and 104 weeks in China

Study Arms (2)

Long term medication assisted treatment (LT-MAT)

EXPERIMENTAL

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Drug: Buprenorphine/Naloxone

Short term medication assisted treatment (ST-MAT)

EXPERIMENTAL

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Drug: Buprenorphine/Naloxone

Interventions

Buprenorphine/Naloxone DRUG

Oral tablet

Also known as: BUP/NX

Long term medication assisted treatment (LT-MAT); Short term medication assisted treatment (ST-MAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-uninfected within 28 days of enrollment
• Meets DSM-IV criteria for opiate dependence
• Positive urine test for opiates
• Injected opiates at least 12 times in the 28 days prior to enrollment, according to self-report
• Willing to use acceptable forms of contraception for the first 12 months of the study
• Able to provide contact information and willing to be contacted by study staff as necessary
• Available for study visits for at least 2 years

You may not qualify if:

• Current treatment with methadone, morphine, levo-alpha-acetyl-methadol (LAAM), naltrexone, or nalmefene
• Currently enrolled in another HIV prevention or drug use intervention study
• Known sensitivity to buprenorphine or naloxone
• Requires immediate medical attention for dependence on alcohol, benzodiazepines, or other substances. People who are dependent on tobacco are not excluded.
• Currently injecting drugs of abuse other than opiates, more than twice in the last 28 days, according to self-report
• Psychological disturbance or cognitive impairment that may interfere with the study
• Acute or chronic kidney failure
• Certain abnormal laboratory values
• Any other medical or psychiatric condition that, in the opinion of the investigator, would make participation in this study unsafe
• Pregnant or breastfeeding
• Current or former participant in HPTN 058 study in Xinjiang who was actively in the long-term treatment arm on stable maintenance dose of Suboxone when detained/arrested (last dose within 2 days of incarceration), resulting in immediate cessation of Suboxone without tapering
• Currently released from detention
• Willing to complete one-time questionnaire
• Willing to sign informed consent
• Any medical or psychiatric condition that, in the opinion of the investigator, would make participation in the study unsafe, or would otherwise interfere with the study objectives or interpretation

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Heng County Ctr. for Disease Control & Prevention CRS

Hengzhou Town, Guangxi, 530300, China

Location

Guangxi Ctrs. for Disease Control & Prevention and for HIV/AIDS Prevention & Control CRS

Nanning, Guangxi, 530028, China

Location

Xinjiang CRS

Ürümqi, Xinjiang, 830011, China

Location

CMU HIV Prevention CRS

Chiang Mai, 50200, Thailand

Location

Related Publications (7)

• Aceijas C, Stimson GV, Hickman M, Rhodes T; United Nations Reference Group on HIV/AIDS Prevention and Care among IDU in Developing and Transitional Countries. Global overview of injecting drug use and HIV infection among injecting drug users. AIDS. 2004 Nov 19;18(17):2295-303. doi: 10.1097/00002030-200411190-00010.

  PMID: 15577542 BACKGROUND

• Gowing L, Farrell M, Bornemann R, Ali R. Substitution treatment of injecting opioid users for prevention of HIV infection. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004145. doi: 10.1002/14651858.CD004145.pub2.

  PMID: 15495080 BACKGROUND

• Koester S, Glanz J, Baron A. Drug sharing among heroin networks: implications for HIV and hepatitis B and C prevention. AIDS Behav. 2005 Mar;9(1):27-39. doi: 10.1007/s10461-005-1679-y.

  PMID: 15812611 BACKGROUND

• Raisch DW, Fye CL, Boardman KD, Sather MR. Opioid dependence treatment, including buprenorphine/naloxone. Ann Pharmacother. 2002 Feb;36(2):312-21. doi: 10.1345/aph.10421.

  PMID: 11847954 BACKGROUND

• Ruan Y, Qin G, Liu S, Qian H, Zhang L, Zhou F, He Y, Chen K, Yin L, Chen X, Hao Q, Xing H, Song Y, Wang Y, Hong K, Chen J, Shao Y. HIV incidence and factors contributed to retention in a 12-month follow-up study of injection drug users in Sichuan Province, China. J Acquir Immune Defic Syndr. 2005 Aug 1;39(4):459-63. doi: 10.1097/01.qai.0000152398.47025.0f.

  PMID: 16010170 BACKGROUND

• Lucas GM, Beauchamp G, Aramrattana A, Shao Y, Liu W, Fu L, Jackson JB, Celentano DD, Richardson P, Metzger D; HPTN 058 study group. Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058. Int J Drug Policy. 2012 Mar;23(2):162-5. doi: 10.1016/j.drugpo.2011.06.005. Epub 2011 Aug 17.

  PMID: 21852093 DERIVED

• Sugarman J, Corneli A, Donnell D, Liu TY, Rose S, Celentano D, Jackson B, Aramrattana A, Wei L, Shao Y, Liping F, Baoling R, Dye B, Metzger D. Are there adverse consequences of quizzing during informed consent for HIV research? J Med Ethics. 2011 Nov;37(11):693-7. doi: 10.1136/jme.2011.042358. Epub 2011 Jun 8.

  PMID: 21653649 DERIVED

MeSH Terms

Conditions

HIV Infections; Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Senior Statistical Analyst
• Organization: Fred Hutchinson Cancer Research Center

geetha@scharp.org

206-667-6167

Study Officials

• David Metzger, PhD

  Center for Studies of Addiction, University of Pennsylvania

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: May 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 5, 2021
• Results First Posted: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); TH (1)