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Antiretroviral Treatment Strategies in Relation to Adherence, Resistance and Virological Treatment Failure (DotArv)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Mattias Larsson, Karolinska Institutet.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Karolinska Institutet
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
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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 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 |
Resource links provided by NLM:
Further study details as provided by Mattias Larsson, Karolinska Institutet:
Primary Outcome Measures:
- 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:
- 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.
- Clinical treatment failure [ Time Frame: 24 months ]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:
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Show Detailed Description
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01433601
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
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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017