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

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ClinicalTrials.gov Identifier: NCT01433601
Recruitment Status : Unknown
Verified September 2011 by Mattias Larsson, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
Sponsor:
Collaborator:
Hanoi Medical University
Information provided by (Responsible Party):
Mattias Larsson, Karolinska Institutet

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Behavioral: Enhanced Treatment Support (ETS) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2007
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Virological treatment failure [ Time Frame: 24 months ]
    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 :
  1. Immunological treatment failure [ Time Frame: 24 months ]

    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.

  2. Clinical treatment failure [ Time Frame: 24 months ]
    Occurrence or recurrence of stage 4 diseases or conditions after at least 6 months of therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Mattias Larsson, Karolinska Institutet:
Adherence
Peer support
Treatment failure

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