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

NCT01433601 | Unknown DMC

• 1 other identifier: DotArv_Vietnam
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Adherence; Peer support; Treatment failure

Outcome Measures

Primary Outcomes (1)

• Virological treatment failure

  HIV viral load of 1 fg reverse transcriptase activity/ml, corresponding to 200 copies/ml, at 1 year and 2 years after starting treatment.

  24 months

Secondary Outcomes (2)

• Immunological treatment failure

  24 months

• Clinical treatment failure

  24 months

Study Arms (2)

Self Supervised Treatment (SST)

NO INTERVENTION

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.

Enhanced Treatment Support (ETS)

EXPERIMENTAL

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)

Interventions

Enhanced Treatment Support (ETS) BEHAVIORAL

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.

Also known as: Peer support, Directly Observed Treatment (DOT), Adherence support, Adherence counselling

Enhanced Treatment Support (ETS)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Ongoing severe opportunistic infections
• Institutionalized patients.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Hanoi Medical University: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Hanoi, 01, Vietnam

Location

Related Publications (3)

• Cuong DD, Sonnerborg A, Van Tam V, El-Khatib Z, Santacatterina M, Marrone G, Chuc NT, Diwan V, Thorson A, Le NK, An PN, Larsson M. Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam. BMC Infect Dis. 2016 Dec 16;16(1):759. doi: 10.1186/s12879-016-2017-x.

  PMID: 27986077 DERIVED

• Van Tam V, Cuong DD, Alfven T, Phuc HD, Chuc NT, Hoa NP, Diwan V, Larsson M. HIV sero-discordance among married HIV patients initiating anti-retroviral therapy in northern Vietnam. AIDS Res Ther. 2016 Nov 15;13:39. doi: 10.1186/s12981-016-0124-9. eCollection 2016.

  PMID: 27891160 DERIVED

• Cuong do D, Thorson A, Sonnerborg A, Hoa NP, Chuc NT, Phuc HD, Larsson M. Survival and causes of death among HIV-infected patients starting antiretroviral therapy in north-eastern Vietnam. Scand J Infect Dis. 2012 Mar;44(3):201-8. doi: 10.3109/00365548.2011.631937. Epub 2011 Nov 28.

  PMID: 22122590 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mattias Larssson, Md PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 14, 2011
• Study Start: August 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 14, 2011

Record last verified: 2011-09

Locations

VN (1)