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QoL and Adherence to One-pill Once-a-day HAART (ADONE)
This study has been completed.
Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT00990600
First received: October 6, 2009
Last updated: October 28, 2009
Last verified: October 2009
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Purpose
Primary objective of the study is:
To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infection HIV Infections | Other: reduced number of pills | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adherence to a One Pill, Once-a-day Antiretroviral Regimen |
Resource links provided by NLM:
Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:
Primary Outcome Measures:
- Proportion of adherence to HAART [ Time Frame: 6 months ]
Secondary Outcome Measures:
- QoL (VAS scale) preferences of patients virologic and immunologic outcomes [ Time Frame: 6 months ]
| Enrollment: | 212 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Simplified one pill regimen
Fixed dose combination of tenofovir + emtricitabine + efavirenz
|
Other: reduced number of pills
Switch to a fixed dose combination one pill/daily HAART
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Informed consent signed
- Effective ongoing treatment (HIV-RNA < 50 copies/ml) for at least three months
-
Being on a stable HAART regimen based either on two possible drug associations:
- 3TC/FTC + TDF + EFV
- FTC/TDF (fixed dose combination) + EFV
- No previous documented virologic failure
Exclusion Criteria:
- Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
- Any ongoing grade 4 laboratory abnormality
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990600
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990600
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
| Principal Investigator: | Franco Maggiolo, MD | Ospedali Riuniti, Bergamo |
More Information
| Responsible Party: | Franco Maggiolo MD, Divisione di Malattie Infettive, Ospedali Riuniti, Bergamo |
| ClinicalTrials.gov Identifier: | NCT00990600 History of Changes |
| Other Study ID Numbers: |
ADONE EUDRACT NUMBER: 2007-007839-33 |
| Study First Received: | October 6, 2009 |
| Last Updated: | October 28, 2009 |
Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
|
adherence Qol virologic efficacy immunologic efficacy |
patients' preference once-daily HAART treatment experienced |
Additional relevant MeSH terms:
|
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Tenofovir Efavirenz |
Emtricitabine 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 |
ClinicalTrials.gov processed this record on July 24, 2017