Antiretroviral Treatment Strategies in Relation to Adherence, Resistance and Virological Treatment Failure (DotArv)
|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
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus (HIV)||Behavioral: Enhanced Treatment Support (ETS)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||640 participants|
|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|
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433601
|Hanoi Medical University|
|Hanoi, Vietnam, 01|
|Principal Investigator:||Mattias Larssson, Md PhD||Karolinska Institutet|