A Randomised Controlled Trial to Assess Antiretroviral Treatment Strategies in Relation to Adherence, Resistance and Virological Treatment Failure

Aim To study the impact of patient support on selective drug pressure, defined by semi-quantitative assessments of adherence, on the viral suppression and resistance development through a randomised controlled trial of HIV positive patients randomised in enhanced treatment support (ETS) and self supervised treatment (SST).

Specific Objectives

1. To create a study population 600 HIV+ patients with CD4+ T-cell count of <200/ul and randomize in two different treatment cohorts, enhanced treatment support (ETS) and conventional self-supervised treatment (SST).
2. To monitor the patients using semi-quantitative assessments of adherence, clinical status including clinical examinations (every 3 months), viral load and CD4+ T-cell count (every 6 months) during 24 months with virological treatment failure as primary endpoint.
3. To compare the ETS and SST cohorts with respect to the primary endpoint, virological treatment failure, in relation to the semi-quantitative assessments of adherence and to analyse the mechanism of selective drug pressure for the development of resistance including resistance in minor viral subpopulations.
4. To conduct a cost effectiveness assessment comparing ETS and SST with respect to the labour and infrastructural cost, virological treatment failure and change to second line therapy.

The study is conducted in Quang Ninh Province, the area hardest hit by the HIV epidemic in Vietnam with a known HIV+ prevalence above 1%. A study population of 600 HIV+ patients with CD4+ T-cell count of <200 are being be recruited in four districts, Ha Long, Uong Bi, Yen Huong and Dong Trieu. Each HIV+ person is examined according to WHO guidelines. HIV+ persons receive a complete physical examination, clinical staging of HIV infection, opportunistic infections including HBV, HCV and tuberculosis. Laboratory testing will include Full blood count, CD4+ T-cell count, viral load using the affordable and simple ELISA based ExaVirR viral load test (http://www.cavidi.se), liver enzymes, PAP smear and pregnancy test for women. If indicated (e.g. prolonged cough) chest X-ray, sputum microscopy for AFB are done.

Opportunistic infections in HIV+ patients are treated according to national guidelines. HIV+ persons receive counselling including information about the disease and the plan for care and treatment, follow-up visits, nutrition and living, prevention of HIV transmission including safe sex, harm reduction measures, the use of birth control methods and prevention of mother to child HIV transmission.