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

NCT01433601 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2011-09-14

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Mattias Larssson, Md PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433601 on ClinicalTrials.gov