Antiretroviral Treatment Strategies in Relation to Adherence, Resistance and Virological Treatment Failure (DotArv)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Karolinska Institutet.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hanoi Medical University
Information provided by (Responsible Party):
Mattias Larsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01433601
First received: September 9, 2011
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

This project aims to assess different antiretroviral treatment strategies, optimally controlled and conventional, in relation to drug resistance and virological treatment failure. A Randomised Controlled trial (RCT) where Vietnamese HIV+ patients with CD4+ T-cells <200/ul are randomized into either enhanced treatment support (ETS) through peer supporters or The National AIDS Control Program recommended self supervised treatment (SST). The treatment strategies will be assessed and compared in relation to treatment adherence and drug resistance development with virological treatment failure as primary endpoint. The results from this project will lead to an increased knowledge in relation the impact of treatment support on adherence, virological suppression and resistance development and have an impact on HIV treatment policies in low income settings globally.


Condition Intervention
Human Immunodeficiency Virus (HIV)
Behavioral: Enhanced Treatment Support (ETS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial to Assess Antiretroviral Treatment Strategies in Relation to Adherence, Resistance and Virological Treatment Failure

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Virological treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    HIV viral load of 1 fg reverse transcriptase activity/ml, corresponding to 200 copies/ml, at 1 year and 2 years after starting treatment.


Secondary Outcome Measures:
  • Immunological treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Immunological treatment failure

    • CD4 count returns to or falls below pre-therapy baseline level or
    • 50% decline from the on-treatment peak value since the initiation of ART (if known); or
    • CD4 count < 100 cells/mm3 after a year without any increase.

  • Clinical treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Occurrence or recurrence of stage 4 diseases or conditions after at least 6 months of therapy


Enrollment: 640
Study Start Date: August 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Self Supervised Treatment (SST)
Treatment according to the National Treatment Guidelines in Vietnam including treatment counseling before initiation of ART and clinical follow up every 3 months. The patient is self responsible to take the drugs and no additional adherence support is provided.
Experimental: Enhanced Treatment Support (ETS)
Treatment according to the National Treatment Guidelines in Vietnam including treatment counseling before initiation of ART and clinical follow up every 3 months. In addition adherence support is provided according to the description under intervention.
Behavioral: Enhanced Treatment Support (ETS)
An "internal supporter" - family member or other person trusted by the patient is trained to fill in a checklist whether the drugs has been taken and if this was observed. An"external supporter" - a peer selected PLWHA visit the patient twice weekly the first two months. The external supporter follows a checklist and ask about general well being, psychological problems or adverse drugs reactions as well as go through the adherence since last visit, using the internal supporter checklist. If the adherence is good, the number of visits are decreased to once weekly after two months, if not, the number of visits are intensified. If there are any symptoms of opportunistic infections, immunological reconstruction syndrome or adverse drug reactions the patient are refered for medical checkup.
Other Names:
  • Peer support
  • Directly Observed Treatment (DOT)
  • Adherence support
  • Adherence counselling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • WHO stage IV of HIV disease, regardless of the CD4 count
  • WHO stage III of HIV disease with a CD4 count < 350/mm3
  • WHO stages I or II with a CD4 count < 200/mm3

Exclusion Criteria:

  • Pregnancy
  • Ongoing severe opportunistic infections
  • Institutionalized patients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433601

Locations
Vietnam
Hanoi Medical University
Hanoi, Vietnam, 01
Sponsors and Collaborators
Karolinska Institutet
Hanoi Medical University
Investigators
Principal Investigator: Mattias Larssson, Md PhD Karolinska Institutet
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mattias Larsson, MD PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01433601     History of Changes
Other Study ID Numbers: DotArv_Vietnam
Study First Received: September 9, 2011
Last Updated: September 13, 2011
Health Authority: Vietnam: Ministry of Health

Keywords provided by Karolinska Institutet:
Adherence
Peer support
Treatment failure

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014