Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey
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| ClinicalTrials.gov Identifier: NCT01322932 |
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Recruitment Status
:
Completed
First Posted
: March 25, 2011
Last Update Posted
: December 22, 2015
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| Condition or disease |
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| HIV Infection |
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.
| Study Type : | Observational |
| Actual Enrollment : | 95 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | October 2011 |
| Actual Study Completion Date : | February 2012 |
- Patient adherence [ Time Frame: V0, V1, V2 ]by questionnaire in both subgroups and by MEMS data in the adherence subgroup
- Adverse events and symptoms [ Time Frame: V0, V1, V2 ]by questionnaires
- Treatment management [ Time Frame: V0, V1, V2 ]Treatment management according to meals, timing, disruptive daily schedule By questionnaire
- Patient satisfaction of the switch [ Time Frame: V1, V2 ]By questionnaire
- Impact of switch on clinical outcomes [ Time Frame: V0, V1, V2 ]Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file
- Patients' acceptance of switch [ Time Frame: V-1 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322932
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire | |
| Lausanne, Vaud, Switzerland, 1011 | |
| Study Chair: | Matthias Cavassini, M.D | Centre Hospitalier Universitaire Vaudois | |
| Principal Investigator: | Marie-Paule Schneider, PhD | Policlinique Médicale Universitaire | |
| Study Chair: | Olivier Bugnon, Professor | Policlinique Médicale Universitaire | |
| Principal Investigator: | Aurélie Gertsch, PhD Student | Policlinique Médicale Universitaire |
| Responsible Party: | Marie Schneider, Pharmacist, PhD, Policlinique Médicale Universitaire |
| ClinicalTrials.gov Identifier: | NCT01322932 History of Changes |
| Other Study ID Numbers: |
151/10 |
| First Posted: | March 25, 2011 Key Record Dates |
| Last Update Posted: | December 22, 2015 |
| Last Verified: | December 2015 |
Keywords provided by Marie Schneider, Policlinique Médicale Universitaire:
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Medication Adherence HIV Infection efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name] efavirenz |
emtricitabine Patient Satisfaction tenofovir disoproxil fumarate |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Emtricitabine Efavirenz Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |