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HIV InfectionsPhase 3NCT00270257

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

A Phase 3 study testing Buprenorphine/Naloxone in people with HIV Infections and Opioid-Related Disorders, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections, Opioid-Related Disorders
What is being tested?
Buprenorphine/Naloxone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,251 participants
Where
4 sitesin 2 countries
Study dates
May 2008to Jul 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • Available for study visits for at least 2 years
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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
  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

China3 sites

  • Heng County Ctr. for Disease Control & Prevention CRS

    Hengzhou Town, Guangxi, 530300

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

    Nanning, Guangxi, 530028

  • Xinjiang CRS

    Ürümqi, Xinjiang, 830011

Other trials in China

Thailand1 site

  • CMU HIV Prevention CRS

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors

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.

Read the detailed description

Effective HIV prevention among injection drug users (IDUs) requires educating the at-risk population about HIV transmission and risky behavior, and providing the means for behavior change. Current treatment for opiate dependence focuses on reducing the frequency of drug use. BUP/NX is a combination pill currently used to treat opiate-dependent individuals. This trial will evaluate the effectiveness of two therapies in preventing HIV transmission among IDUs. Drug and risk reduction counseling combined with either long term medication assisted treatment (LT-MAT) with BUP/NX or short term medication assisted treatment (ST-MAT) with BUP/NX will be compared in preventing the transmission of HIV among opiate-dependent individuals.

This study will last 4.5 years. Participants in this study will be randomly assigned to one of two treatment arms. Group 1 will receive LT-MAT with BUP/NX. Group 2 will receive ST-MAT with BUP/NX. An initial 4-week safety and feasibility phase will involve the first 50 participants at each site and will last approximately 30 weeks. Study visits will occur every week and will include a physical exam and blood and urine collection.

The main treatment phase of the study will last 52 weeks. Participants in Group 1 will receive BUP/NX under the tongue, at first daily and then three times a week for 52 weeks. Participants assigned to Group 1 will take part in a BUP/NX reduction phase, which will occur between Weeks 47 and 52. Participants in Group 2 will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator. Participants assigned to Group 2 will receive BUP/NX for a maximum of 18 days; detoxification may be repeated at Week 26 if the participant is still injecting opiates. After Week 4 of the safety phase and Weeks 26 and 52 of the overall study, participants will complete an intervention acceptability assessment.

In addition, participants in both groups will attend drug and risk reduction counseling weekly. After the first 12 weeks, participants will return every 4 weeks for 10 more counseling sessions. HIV testing, hepatitis C testing, risk assessment, and urine tests for opiates will occur at screening and at Weeks 26, 52, 78, 104, 130 and 156. Plasma from blood samples will be stored at each of these visits. Hepatitis B testing will occur at Week 26. Participants in China will attend study visits through approximately Week 104, and participants in Thailand will attend study visits through approximately Week 156.

Participants in China who have been incarcerated may participate in an optional substudy, which is examining the withdrawal effects from BUP/NX after incarceration. Participants who agree to take part in the substudy will attend one study visit and will complete a questionnaire.

Being tested
Buprenorphine/Naloxone
Keywords
HIV Seronegativity, Opiate Addiction, Opiate Dependence
Medical subject headings
HIV Infections, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buprenorphine/NaloxoneDrug

    Also called BUP/NX

    Oral tablet

Study groups in NCT00270257
Study groupRoleWhat they receive
Long term medication assisted treatment (LT-MAT)ExperimentalParticipants 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
Receives: Drug: Buprenorphine/Naloxone
Short term medication assisted treatment (ST-MAT)ExperimentalParticipants 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.
Receives: Drug: Buprenorphine/Naloxone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: For visits up to week 104

Secondary outcomes (6)

  1. Number of Participants With Urinalysis Results Positive for Opiates

    Urine drug screen were assessed monthly and semiannually.

    Measured: Measured through Week 104

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

    All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits.

    Measured: Measured through Week 104

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

    Measured: Measured through Week 104

  4. Self-reported Number of Injections in the Last Month

    Measured: Measured through Week 104

  5. Incident Hepatitis C Infections for Thailand and China

    HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.

    If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint).

    Analysis was done separately for both countries

    Measured: Measured through week 156 in Thailand and 104 weeks in China

  6. Incident Hepatitis B Infections

    Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg.

    Measured: Measured through week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2005 (estimated)
  2. Study startMay 2008
  3. Primary completionJul 2012
  4. Study completionJul 2012

Why it stopped: DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00270257
Sponsor's protocol ID
HPTN 058
Other IDs
10144
Status last verified
Dec 2016
First submitted
22 Dec 2005
Last updated
5 Nov 2021
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 15577542

  • 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.

    PubMed 15495080

  • 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.

    PubMed 15812611

  • 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.

    PubMed 11847954

  • 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.

    PubMed 16010170

  • 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.

    PubMed 21852093

  • 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.

    PubMed 21653649

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Buprenorphine/Naloxone in people with HIV Infections and Opioid-Related Disorders, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks (time frame: For visits up to week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00270257, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.

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