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Completed

NCT Number: NCT01322932

Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey

The purpose of this study is to assess adherence, tolerability and satisfaction of each eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.

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Key information

Conditions

HIV Infection Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance Patient Satisfaction RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

Each eligible patient will be screened from de SHCS database. Each refusal and drop-out will be documented. A pre-visit (V-1) will be scheduled for informed consent, V0 for inclusion (V-1 and V0 may occur on the same day), V1 one month post-inclusion and V2 4 to 7 months post-inclusion. V0, V1 and V2 will be planned during regular medical visits.

Eligible patients either get their cART in their usual pharmacy according to standard of care, or take part in a routine adherence-enhancing program(adherence subgroup)run by the pharmacists of the outpatient medical clinic.

In the adherence subgroup, adherence is assessed electronically by MEMS (Medication event monitoring system) monitors on a regular basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients under TDF-FTC-EFV
  • followed up at the Service of Infectious Disease of the University Hospital of Lausanne
  • enrolled in the SHCS

Exclusion criteria

  • patients receiving TDF-FTC-EFV in combination with other ARTs
  • patients under TDF-FTC-EFV for less than 3 months
  • patients not fluent in French

Treatment and study plan

Primary outcomes

  1. Patient adherence

    Time frame: V0, V1, V2

    by questionnaire in both subgroups and by MEMS data in the adherence subgroup

  2. Adverse events and symptoms

    Time frame: V0, V1, V2

    by questionnaires

  3. Treatment management

    Time frame: V0, V1, V2

    Treatment management according to meals, timing, disruptive daily schedule By questionnaire

  4. Patient satisfaction of the switch

    Time frame: V1, V2

    By questionnaire

Secondary outcomes

  1. Impact of switch on clinical outcomes

    Time frame: V0, V1, V2

    Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file

  2. Patients' acceptance of switch

    Time frame: V-1

Sponsors and collaborators

Lead sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois
  • Gilead Sciences
  • Swiss HIV Cohort Study

Registry information

Official study title

HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 25, 2011
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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